7-DAY
`TREATMENT
`
`Cream
`
`Cream with 1 Reusable Applicator
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`Net Wt. 1.59 oz (45 g) Tube + 1 Reusable Applicator
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS022103
`
`If you have any
`questions or
`comments,
`please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`OPEN HERE
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`If you have any questions or comments, please call 1-877-666-4782
`Questions?
`potassium hydroxide, propylene glycol, purified water, stearyl alcohol
`benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60,
`Inactive ingredients
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`Other information
`• children under 12 years of age: ask a doctor
`outside the vagina. Use 2 times daily for up to 7 days, as needed.
`onto your fingertip. Apply the cream onto the itchy, irritated skin
`the skin outside the vagina. Squeeze a small amount of cream
`• use the same tube of cream if you have itching and irritation on
`nights in a row. Wash applicator after use.
`• applicator: insert 1 applicatorful into the vagina at bedtime for 7
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if
`using another product
`• if you do not get complete relief ask a doctor before
`Drug Facts (continued)
`
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`weakened immune system.
`medical cause for your symptoms, including diabetes, or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a more
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`by a doctor
`Do not use if you have never had a vaginal yeast infection diagnosed
`For vaginal use only
`Warnings
`yeast infection
`• relieves external itching and irritation due to a vaginal
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2%....................................................Vaginal antifungal
`Active ingredients
`Purpose
`Drug Facts
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT
`UNIT DO NOT USE
`IF SEAL OVER
`TUBE HAS BEEN
`PUNCTURED.
`
`

`

`7-DAY
`TREATMENT
`
`Cream
`
`Cream with
`7 Disposable Applicators
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`Net Wt. 1.59 oz (45 g) Tube + 7 Disposable Applicators
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS025103
`
`If you have any
`questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`using another product
`• if you do not get complete relief ask a doctor before
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`that causes AIDS
`• been exposed to the human immunodeficiency virus (HIV)
`weakened immune system.
`medical cause for your symptoms, including diabetes or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a more
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`by a doctor.
`Do not use if you have never had a vaginal yeast infection diagnosed
`For vaginal use only
`Warnings
`• relieves external itching and irritation due to a vaginal yeast infection
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2%....................................................Vaginal antifungal
`Active ingredients
`Purpose
`Drug Facts
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`please call 1-877-666-4782
`If you have any questions or comments,
`Questions?
`potassium hydroxide, propylene glycol, purified water, stearyl alcohol
`benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60,
`Inactive ingredients
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`Other information
`• children under 12 years of age: ask a doctor
`outside the vagina. Use 2 times daily for up to 7 days as needed.
`onto your fingertip. Apply the cream onto the itchy, irritated skin
`the skin outside the vagina. Squeeze a small amount of cream
`• use the same tube of cream if you have itching and irritation on
`7 nights in a row. Throw applicator away after use.
`• applicators: insert 1 applicatorful into the vagina at bedtime for
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if
`Drug Facts (continued)
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT
`UNIT DO NOT USE
`IF SEAL OVER
`TUBE HAS BEEN
`PUNCTURED.
`
`

`

`COMBINATION PACK
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`7-DAY
`TREATMENT
`COMBINATION PACK
`
`Cream
`
`Cream with
`7 Disposable Applicators
`
`plus External Cream
`for Itch Relief
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`C O M B I N A T I O N P A C K
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`C O M B I N A T I O N P A C K
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`Lot
`
`Exp
`
`Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube + 7 Disposable Applicators
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS001108
`
`If you have any
`questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`please call 1-877-666-4782
`Questions? If you have any questions or comments,
`purified water, stearyl alcohol
`myristate, polysorbate 60, potassium hydroxide, propylene glycol,
`Inactive ingredients benzoic acid, cetyl alcohol, isopropyl
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`Other information
`• children under 12 years of age: ask a doctor
`the vagina. Use 2 times daily for up to 7 days, as needed.
`fingertip. Apply the cream onto the itchy, irritated skin outside
`• external cream: squeeze a small amount of cream onto your
`7 nights in a row. Throw applicator away after use.
`• applicator: insert 1 applicatorful into the vagina at bedtime for
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if
`Drug Facts (continued)
`
`using another product
`• if you do not get complete relief ask a doctor before
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`or bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`weakened immune system.
`medical cause for your symptoms, including diabetes, or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`more serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`diagnosed by a doctor.
`Do not use if you have never had a vaginal yeast infection
`For vaginal use only
`Warnings
`infection
`• relieves external itching and irritation due to a vaginal yeast
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2% (external cream)...................Vaginal antifungal
`Miconazole nitrate 2%.....................................................Vaginal antifungal
`Active Ingredients
`Purpose
`Drug Facts
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal7
`
`COMBINATION PACK
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT UNIT
`DO NOT USE IF SEAL OVER TUBE
`HAS BEEN PUNCTURED.
`
`

`

`3-DAY
`TREATMENT
`COMBINATION PACK
`
`Ovule®
`
`3 Ovule® Inserts
`
`Plus External Cream
`for Itch Relief
`
`CRTN-0905
`
`Miconazole Nitrate Vaginal Insert (200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`C O M B I N A T I O N P A C K 3
`C O M B I N A T I O N P A C K 3
`
`Miconazole Nitrate Vaginal Insert (200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`3 OVULE® Inserts Net Wt. 2.5 g each + 0.32 oz (9 g) Tube
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS036103
`
`If you have any
`questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`COMBINATION PACK3
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Insert (200 mg) and
`
`please call 1-877-666-4782
`Questions? If you have any questions or comments,
`water, stearyl alcohol
`polysorbate 60, potassium hydroxide, propylene glycol, purified
`external cream: benzoic acid, cetyl alcohol, isopropyl myristate,
`titanium dioxide
`vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base,
`Inactive ingredients
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`torn, open or incompletely sealed
`• do not use if printed sealed pouches containing vaginal inserts are
`Other information
`• children under 12 years of age: ask a doctor
`vagina. Use 2 times daily for up to 7 days, as needed.
`fingertip. Apply the cream onto the itchy, irritated skin outside the
`• external cream: squeeze a small amount of cream onto your
`the vagina at bedtime. Throw applicator away after use.
`• vaginal insert: with a disposable applicator, place the insert into
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if:
`Drug Facts (continued)
`
`using another product
`• if you do not get complete relief ask a doctor before
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`weakened immune system.
`medical cause for your symptoms, including diabetes, or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a more
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`by a doctor.
`Do not use if you have never had a vaginal yeast infection diagnosed
`For vaginal use only
`Warnings
`• relieves external itching and irritation due to a vaginal yeast infection
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2% (external cream)....................Vaginal antifungal
`Miconazole nitrate (200 mg in each vaginal insert)..Vaginal antifungal
`Active ingredients
`Purpose
`Drug Facts
`COMBINATION PACK3
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Insert (200 mg) and
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT
`UNIT DO NOT USE
`IF PRINTED SEALED
`POUCH AND SEAL
`OVER TUBE ARE
`TORN, OPENED OR
`INCOMPLETELY
`SEALED
`
`

`

`3-DAY
`TREATMENT
`COMBINATION PACK
`
`Suppository
`
`Vaginal Suppositories
`with 3 Applicators
`
`plus External Cream
`for Itch Relief
`
`CRTN-0911
`
`Miconazole Nitrate Vaginal Suppositories (200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`C O M B I N A T I O N P A C K 3
`C O M B I N A T I O N P A C K 3
`
`Miconazole Nitrate Vaginal Suppositories (200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`3 Suppositories Net Wt. 2.5 g each + 0.32 oz (9 g) Tube
`
`Dist. by Insight Pharmaceuticals LLC,
`Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by
`Insight Pharmaceuticals LLC.
`All rights reserved. MNUS028103
`
`If you have any
`questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`COMBINATION PACK3
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Suppositories (200 mg) and
`
`using another product
`• if you do not get complete relief ask a doctor before
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`weakened immune system.
`medical cause for your symptoms, including diabetes, or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`more serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`diagnosed by a doctor.
`Do not use if you have never had a vaginal yeast infection
`For vaginal use only
`Warnings
`yeast infection
`• relieves external itching and irritation due to a vaginal
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2% (external cream)..................Vaginal antifungal
`Miconazole nitrate (200 mg in each suppository)...Vaginal antifungal
`Active ingredients
`Purpose
`Drug Facts
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Suppositories (200 mg) and
`
`COMBINATION PACK3
`
`please call 1-877-666-4782
`Questions? If you have any questions or comments,
`
`water, stearyl alcohol
`polysorbate 60, potassium hydroxide, propylene glycol, purified
`external cream: benzoic acid, cetyl alcohol, isopropyl myristate,
`suppository: hydrogenated vegetable oil base
`Inactive ingredients
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`incompletely sealed
`• do not use if printed suppository blisters are torn, open or
`Other Information
`• children under 12 years of age: ask a doctor
`the vagina. Use 2 times daily for up to 7 days, as needed.
`fingertip. Apply the cream onto the itchy, irritated skin outside
`• external cream: squeeze a small amount of cream onto your
`for three nights in a row. Throw applicator away after use.
`• suppositories: insert 1 suppository into the vagina at bedtime
`• adults and children 12 years of age and over:
`information leaflet for complete directions and information
`• before using this product read the enclosed consumer
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if:
`Drug Facts (continued)
`
`Lot
`
`Exp
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT UNIT
`DO NOT USE IF
`PRINTED SUPPOSITORY
`BLISTERS OR SEAL
`OVER TUBE ARE TORN,
`OPENED OR
`INCOMPLETELY
`SEALED
`
`

`

`3-DAY
`TREATMENT
`
`Prefilled Cream
`Applicator
`
`3 Ready-to-Use Prefilled Applicators
`
`Miconazole Nitrate Vaginal Cream (4%) — Vaginal Antifungal3
`Miconazole Nitrate Vaginal Cream (4%) — Vaginal Antifungal3
`
`✓ CURES most vaginal YEAST INFECTIONS
`
`3 Prefilled Applicators Net Wt. 0.18 oz (5 g) each
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS009103
`
`If you have any
`questions or
`comments,
`please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`Miconazole Nitrate Vaginal Cream (4%) — Vaginal Antifungal3
`
`
`
`using another product
`• if you do not get complete relief ask a doctor before
`• mild increase in vaginal burning, itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`or a weakened immune system.
`medical cause for your symptoms, including diabetes,
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a more
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`by a doctor.
`Do not use if you have never had a vaginal yeast infection diagnosed
`For vaginal use only
`Warnings
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 4%...................................................Vaginal antifungal
`Active ingredient
` Purpose
`Drug Facts
`
`Miconazole Nitrate Vaginal Cream (4%) — Vaginal Antifungal3
`
`please call 1-877-666-4782
`Questions? If you have any questions or comments,
`potassium hydroxide, propylene glycol, purified water, stearyl alcohol
`benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60,
`Inactive ingredients
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`incompletely sealed
`• do not use if printed applicator wrapper is torn, open or
`Other Information
`• children under 12 years of age: ask a doctor
`row. Throw applicator away after use.
`• insert 1 applicatorful into the vagina at bedtime for 3 nights in a
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if:
`Drug Facts (continued)
`
`Lot
`
`Exp
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT
`UNIT DO NOT USE
`IF PRINTED
`APPLICATOR
`WRAPPER IS TORN,
`OPENED OR
`INCOMPLETELY
`SEALED
`
`

`

`3-DAY
`TREATMENT
`COMBINATION PACK
`
`Prefilled Cream
`Applicator
`
`
`
`3 Ready-to-Use
`Prefilled Applicators
`
`plus External Cream
`for Itch Relief
`
`Miconazole Nitrate Vaginal Cream (4%) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`C O M B I N A T I O N P A C K 3
`C O M B I N A T I O N P A C K 3
`
`Miconazole Nitrate Vaginal Cream (4%) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`Lot
`
`Exp
`
`3 Prefilled Applicators Net Wt. 0.18 oz (5 g) each + 0.32 oz (9 g) Tube
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS013106
`
`If you have any
`questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`
`
`
`
`please call 1-877-666-4782
`Questions? If you have any questions or comments,
`purified water, stearyl alcohol
`myristate, polysorbate 60, potassium hydroxide, propylene glycol,
`Inactive ingredients benzoic acid, cetyl alcohol, isopropyl
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`incompletely sealed
`• do not use if printed applicator wrapper is torn, open or
`Other Information
`• children under 12 years of age: ask a doctor
`vagina. Use 2 times daily for up to 7 days, as needed.
`fingertip. Apply the cream onto the itchy, irritated skin outside the
`• external cream: squeeze a small amount of cream onto your
`nights in a row. Throw applicator away after use.
`• applicators: insert 1 applicatorful into the vagina at bedtime for 3
`• adults and children 12 years of age and over:
`leaflet for complete directions and information
`• before using this product read the enclosed consumer information
`Directions
`contact a Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or
`If pregnant or breast-feeding, ask a health professional before use.
`vomiting, or foul-smelling vaginal discharge
`• you get a rash or hives, abdominal pain, fever, chills, nausea,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if:
`Drug Facts (continued)
`
`Reference ID: 4552130
`
`COMBINATION PACK3
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Cream (4%) and
`
`
`
`
`
`before using another product
`• if you do not get complete relief ask a doctor
`• mild increase in vaginal burning itching or irritation may occur
`• do not have vaginal intercourse
`prevent pregnancy or sexually transmitted diseases (STDs).
`products. Condoms and diaphragms may be damaged and fail to
`• do not use tampons, douches, spermicides or other vaginal
`When using this product
`bruising may occur.
`prescription blood thinning medicine warfarin, because bleeding or
`Ask a doctor or pharmacist before use if you are taking the
`causes AIDS
`• been exposed to the human immunodeficiency virus (HIV) that
`weakened immune system.
`medical cause for your symptoms, including diabetes, or a
`months). You could be pregnant or have a serious underlying
`• vaginal yeast infections often (such as once a month or 3 in 6
`serious condition.
`vomiting, or foul-smelling vaginal discharge. You may have a more
`• lower abdominal, back or shoulder pain, fever, chills, nausea,
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`diagnosed by a doctor.
`Do not use if you have never had a vaginal yeast infection
`For vaginal use only
`Warnings
`• relieves external itching and irritation due to a vaginal yeast infection
`• treats vaginal yeast infections
`Uses
`Miconazole nitrate 2% (external cream)...................Vaginal antifungal
`Miconazole nitrate 4% ...................................................Vaginal antifungal
`Active ingredient
`Purpose
`Drug Facts
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Cream (4%) and
`
`:::::::::~~~
`
`
`
`COMBINATION PACK3
`
`,-~
`
`TAMPER-EVIDENT
`UNIT DO NOT USE IF
`PRINTED APPLICATOR
`WRAPPER OR SEAL
`OVER TUBE ARE
`TORN, OPENED OR
`INCOMPLETELY
`SEALED
`
`

`

`1-DAY
`TREATMENT
`COMBINATION PACK
`
` Day or Night™ OVULE®
`
` Stays in Place
`
`
`
`
`Ovule® Insert
`
`plus External Cream
`for Itch Relief
`
`CRTN-0904
`
`C O M B I N A T I O N P A C K
`Miconazole Nitrate Vaginal Insert (1200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`C O M B I N A T I O N P A C K
`Miconazole Nitrate Vaginal Insert (1200 mg) and
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`
`MAXIMUM
`STRENGTH
`OVULE®
`
`✓ CURES most vaginal YEAST INFECTIONS
`✓ Relieves associated external itching and irritation
`
`1 OVULE® Insert Net Wt. 2.6 g + 0.32 oz (9 g) Tube
`
`Dist. by Insight Pharmaceuticals LLC, Tarrytown, NY 10591
`A Prestige Consumer Healthcare company
`©2019 Trade dress is owned by Insight Pharmaceuticals LLC.
`All rights reserved. MNUS019104
`
`If you have any
`
` questions or
`comments, please call
`1-877-MONISTAT
`(1-877-666-4782)
`
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Insert (1200 mg) and
`C OM B I N A T I O N P A CK
`
`please call 1-877-666-4782
`
`Questions? If you have any questions or comments,
`
`60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
`• external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate
`white petrolatum
`• vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide,
`Inactive ingredients
`complete relief by 7 days.
`symptoms in just 1 day. Most women get some improvement in 1 day and
`• this is a 1-dose treatment. Most women do not get complete relief of their
`• store at 20°-25°C (68°-77°F)
`• do not purchase if carton is open
`• do not use if seal over tube opening has been punctured
`• do not use if printed sealed pouch is torn, open or incompletely sealed
`Other information
`
`• children under 12 years of age: ask a doctor
`for up to 7 days as needed.
`the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily
`
`• external cream: squeeze a small amount of cream onto your fingertip. Apply
`Throw away applicator.
`
`• vaginal insert: with the applicator, place the vaginal insert into the vagina.
`
`• adults and children 12 years of age and over:
`
`complete directions and information
`• before using this product read the enclosed consumer information leaflet for
`Directions
`Poison Control Center right away.
`Keep out of reach of children. If swallowed, get medical help or contact a
`
`
`If pregnant or breast-feeding, ask a health professional before use.
`or foul-smelling vaginal discharge.
`Drug Facts (continued)
`
`
`
`MA XIMUM ST RENG T H OVUL E®
`1-Day Treatment
`
`• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting,
`• symptoms last more than 7 days
`• symptoms do not get better in 3 days
`Stop use and ask a doctor if
`• if you do not get complete relief ask a doctor before using another product
`
`• mild increase in vaginal burning, itching or irritation may occur
`
`• do not have vaginal intercourse
`
`sexually transmitted diseases (STDs).
`Condoms and diaphragms may be damaged and fail to prevent pregnancy or
`• do not use tampons, douches, spermicides or other vaginal products.
`
`When using this product
`thinning medicine warfarin, because bleeding or bruising may occur.
`Ask a doctor or pharmacist before use if you are taking the prescription blood
`• been exposed to the human immunodeficiency virus (HIV) that causes AIDS
`symptoms, including diabetes or a weakened immune system.
`could be pregnant or have a serious underlying medical cause for your
`• vaginal yeast infections often (such as once a month or 3 in 6 months). You
`foul-smelling vaginal discharge. You may have a more serious condition.
`• lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or
`
`• vaginal itching and discomfort for the first time
`Ask a doctor before use if you have
`by a doctor.
`Do not use if you have never had a vaginal yeast infection diagnosed
`For vaginal use only
`Warnings
`
` • relieves external itching and irritation due to a vaginal yeast infection
`
` • treats vaginal yeast infections
`Uses
`Miconazole nitrate 2% (external cream) .. .......... .......... .......... ....... Vaginal antifungal
`Miconazole nitrate 1200 mg (in vaginal insert) .. .......... .......... ....... Vaginal antifungal
`Active ingredients
`Purpose
`Drug Facts
`Miconazole Nitrate Vaginal Cream (2%) — Vaginal Antifungal
`Miconazole Nitrate Vaginal Insert (1200 mg) and
`C OM B I N A T I O N P A CK
`
`LOT
`
`EXP
`
`
`Reference ID: 4552130
`
`TAMPER-EVIDENT
`UNIT DO NOT USE
`IF PRINTED SEALED
`POUCH AND SEAL
`OVER TUBE ARE
`TORN, OPENED OR
`INCOMPLETELY
`SEALED
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`KAREN M MAHONEY
`01/28/2020 04:42:50