MICONAZOLE 7- miconazole nitrate cream 
Shopko Stores Operating Co., LLC

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Miconazole 7

Drug Facts

Active ingredient (in each applicator)

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 right away.

Directions

Other information

Inactive ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

Questions?

Call 1-866-923-4914

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

NDC 37012-035-07

SHOPKO®

*Compare to the active
ingredient in Monistat® 7*

Miconazole 7

Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg Per Applicator)

7 Day Treatment

Educational Brochure
Enclosed

One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 7 Disposable Applicators

Principal Display Panel - 45 g Tube Carton
MICONAZOLE 7 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-035
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (UNII: VW4H1CYW1K) (miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate2 mg  in 100 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:37012-035-071 in 1 CARTON
145 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444401/13/1997
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(37012-035)

Revised: 4/2014
Document Id: ca12b4f1-e74f-4feb-b099-302b2c66d2f5
Set id: 8134e0e6-1b9c-439c-92c6-9efe01e07fc6
Version: 1
Effective Time: 20140402
 
Shopko Stores Operating Co., LLC