MONISTAT 3 Combination Pack - Prefilled App And Cream - DailyMed

MONISTAT 3 COMBINATION PACK- miconazole nitrate  Insight Pharmaceuticals LLC

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MONISTAT 3 Combination Pack - 63736-010

DRUG FACTS

Active ingredients

Miconazole nitrate 4%Miconazole nitrate 2% (external cream)

Purpose

Vaginal antifungalVaginal antifungal

Uses

• treats vaginal yeast infections
• relieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

• vaginal itching and discomfort for the first time
• lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
• vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

• do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
• do not have vaginal intercourse
• mild increase in vaginal burning, itching or irritation may occur
• if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

• symptoms do not get better in 3 days
• symptoms last more than 7 days
• you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• before using this product read the enclosed consumer information leaflet for complete directions and information
• adults and children 12 years of age and over:
• applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw away applicator after use.
• external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
• children under 12 years of age: ask a doctor

Other information

• do not use if printed applicator wrapper is torn, open or incompletely sealed
• do not use if seal over tube opening has been punctured
• do not purchase if carton is open
• store at 20°-25°C (68°-77°F)
• Keep this carton for future reference. It contains important information.

Inactive ingredients

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL

- Kit Carton

MONISTAT® 3

COMBINATION PACK

Miconazole Nitrate Vaginal Cream (4%) and Miconazole Nitrate Cream (2%) - Vaginal Antifungal

3 PREFILLED APPLICATORS             Net Wt. 0.18 oz. (5g) +0.32 oz. (9g) tube 

MONISTAT 3 COMBINATION PACK  miconazole nitrate kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-010

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-010-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 12/10/2009

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 APPLICATOR 15 g Part 2 1 TUBE 9 g

Part 1 of 2 MONISTAT 3  miconazole nitrate cream

Product Information Route of Administration VAGINAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 40 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM)   CETYL ALCOHOL (UNII: 936JST6JCN)   ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)   POLYSORBATE 60 (UNII: CAL22UVI4M)   POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   WATER (UNII: 059QF0KO0R)   STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics Color white Score      Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021261 12/10/2009

Part 2 of 2 MICONAZOLE NITRATE  miconazole nitrate cream

Product Information Route of Administration VAGINAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 10 mg  in 0.5 g

Inactive Ingredients Ingredient Name Strength Benzoic Acid (UNII: 8SKN0B0MIM)   Cetyl Alcohol (UNII: 936JST6JCN)   Isopropyl Myristate (UNII: 0RE8K4LNJS)   Polysorbate 60 (UNII: CAL22UVI4M)   Potassium Hydroxide (UNII: WZH3C48M4T)   Propylene glycol (UNII: 6DC9Q167V3)   Water (UNII: 059QF0KO0R)   Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021261 12/10/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021261 12/10/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 10/2025 Document Id: 03108766-1001-4aac-9dd8-799a63662a25 34390-5 Set id: e1b8ad40-5adb-482a-b532-3f8e30d90128 Version: 9 Effective Time: 20251027  Insight Pharmaceuticals LLC