Miconazole Nitrate by Westminster Pharmaceuticals, LLC Miconazole Nitrate

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICONAZOLE NITRATE- miconazole nitrate powder 
Westminster Pharmaceuticals, LLC

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Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungul

Uses

  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings

  • for external use only

Do not use

  • on children under 2 years of age unless by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of powder over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between toes; wear well - fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athletes foot and ringworm, use daily for 4 weeks
  • for jock itch, use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

  • protect from freezing. Avoid excessive heat.
  • do not use if package is damaged

Inactive ingredients

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, corn starch

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

NDC: 69367-399-85

Miconazole

Antifungul Powder
Treatment

Miconazole Nitrate 2%

Botanical Nutrition For
Sensitive Skin

  • CHG Compatible
  • Paraben Free
  • Hypoallergenic

NET WT. 3 OZ (85g)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
MICONAZOLE NITRATE 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69367-399
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69367-399-8585 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/202405/01/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM00505/16/202405/01/2026
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 5/2024
Document Id: fb56c85a-c638-450e-bd13-05887582e7ed
Set id: 8f3729b8-d866-47dd-92a6-d96ffd4cf11f
Version: 4
Effective Time: 20240516