QUALITY CHOICE  3 DAY VAGINAL- miconazole nitrate cream 
Chain Drug Marketing Association

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Quality Choice®
3 Day Vaginal

Drug Facts

Active ingredient (in each applicator)

Miconazole Nitrate USP 4% (200 mg in each applicator)

Purpose

Vaginal antifungal

Use

treats vaginal yeast infections

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

Other information

Inactive ingredients

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol

Questions or comments?

Call toll-free, 1-800-935-2362, for our 24 hour automated response system.

DISTRIBUTED BY QUALITY CHOICE 43157 WEST NINE MILE ROAD
NOVI, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton

QC
QUALITY
CHOICE
®

Cures Most Vaginal Yeast Infections

3 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (4%)

Vaginal Antifungal

(Miconazole Nitrate 200 mg per applicator)

One 0.9 oz (25 g) tube of 3 Day Vaginal Cream with 3 Disposable Applicators
Consumer Information Leaflet Enclosed

PRINCIPAL DISPLAY PANEL - 25 g Tube Carton
QUALITY CHOICE   3 DAY VAGINAL
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-197
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-197-251 in 1 CARTON
125 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07677303/02/2005
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(63868-197)

Revised: 3/2013
Document Id: 8d8b54e5-1580-48a3-bb39-8e3e61a4e68f
Set id: 67b6e800-ed4f-4855-b7b2-266021014bd6
Version: 1
Effective Time: 20130311
 
Chain Drug Marketing Association