Label: TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF- miconazole nitrate cream
- NDC Code(s): 36800-070-09
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 10, 2013
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each applicator)
Miconazole Nitrate USP 4% (200 mg in each applicator)Close
- treats vaginal yeast infections
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.
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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
- store at 20°-25°C (68°-77°F)
- do not purchase if carton is open
- see end flaps of carton and end of tube for lot number and expiration date
- the tube opening should be sealed. If seal has been broken, do not use product.
- Inactive ingredients
cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.Close
- SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLCClose
ELK GROVE VILLAGE, IL 60007
- PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
MICONAZOLE NITRATE VAGINAL CREAM USP (4%)
(MICONAZOLE NITRATE 200 mg PER APPLICATOR)
- Cures most vaginal yeast infections
One 0.9 oz (25 g) tube of three-day vaginal cream
with three disposable applicators
NET WT 0.9 OZ (25 g) TUBE
Consumer information leaflet enclosed
- INGREDIENTS AND APPEARANCE
TOPCARE MICONAZOLE 3 YEAST INFECTION RELIEF
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-070 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:36800-070-09 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 - Topco Associates LLC (006935977) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-070)