MICONAZOLE NITRATE- miconazole nitrate cream 
Taro Pharmaceuticals U.S.A., Inc.

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Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole nitrate USP 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water.

Questions?

call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

CURES most vaginal YEAST INFECTIONS
Relieves associated external itching and irritation

NDC 51672-2035-6

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
(Miconazole Nitrate 100 mg per application)
Vaginal Antifungal

One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator

Consumer Information Leaflet Enclosed

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2035
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Mineral Oil (UNII: T5L8T28FGP)  
Water (UNII: 059QF0KO0R)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2035-61 in 1 CARTON01/13/1997
145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC:51672-2035-71 in 1 CARTON01/13/1997
245 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444401/13/1997
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2035)

Revised: 1/2020
Document Id: f71c79c6-c274-4175-801e-5fa6e11086dd
Set id: 6b34d0be-4bcd-4dff-b732-7fbd46765019
Version: 2
Effective Time: 20200122
 
Taro Pharmaceuticals U.S.A., Inc.