Label: MONISTAT 3 3 DAY- miconazole nitrate cream
- NDC Code(s): 63736-015-18, 63736-015-25
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 30, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
Warnings
For vaginal use only
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 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 disease (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
-
vaginal itching and discomfort for the first time
-
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:
▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
- children under 12 years of age: ask a doctor
- before using this product read the enclosed consumer information leaflet for complete directions and information
- Other information
- Inactive ingredients
- Questions?
- Active ingredient
- Purpose
- Use
-
Warnings
For vaginal use only.
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 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 disease (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
-
vaginal itching and discomfort for the first time
-
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:
▪ applicator: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Wash applicator after use.
- children under 12 years of age: ask a doctor.
- before using this product, read the enclosed consumer information leaflet for complete directions and information
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MONISTAT 3 3 DAY
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-015 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-015-18 3 in 1 CARTON 03/30/1998 1 5 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 2 NDC:63736-015-25 1 in 1 CARTON 03/30/1998 2 25 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020827 03/30/1998 Labeler - Insight Pharmaceuticals LLC (055665422)
