NDC | 63868-197-25 |
Set ID | 67b6e800-ed4f-4855-b7b2-266021014bd6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA076773 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each applicator)
- Purpose
- Use
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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 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.
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Directions
- before using this product read the 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
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE 3 DAY VAGINAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-197 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 CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-197-25 1 in 1 CARTON 1 25 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076773 03/02/2005 Labeler - Chain Drug Marketing Association (011920774) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(63868-197)