MICONAZOLE NITRATE- miconazorb af powder powder 
Premier Brands of America Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Premier Brands Miconazorb AF Powder

Active ingredient

Miconazole nitrate 2%

​ ​Purpose

Antifungal

Uses

  • for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

​Do not use

on children 2 years of age unless directed by a doctor.

​When using this product​ avoid contact with the eyes

​Stop and ask a doctor if

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

​Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

​Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of product 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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails

​Other information

  • store between 59º - 86ºF
  • lightly shake bottle to loosen settled powder

​Inactive ingredients

aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc

​ ​Questions?

call 1-866-964-0939

Principal Display Panel

Premier

Miconazorb ​AF

Miconazole Nitrate 2%

Anti-fungal Powder

Cures and soothes most athlete's foot, jock itch and ringworm

  • Absorbs moisture
  • Soothes chafing, itching and burning

NET WT 2.5 OZ (71g)

PB Miconazorb Anti-Fungal Powder Talc-01.jpg

MICONAZOLE NITRATE 
miconazorb af powder powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.42 g  in 71 g
Inactive Ingredients
Ingredient NameStrength
ALDIOXA (UNII: 8T66I31YNK)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-020-2571 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201312/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201312/31/2021
Labeler - Premier Brands of America Inc. (117557458)

Revised: 1/2023
Document Id: f32c4937-c5c7-23c8-e053-2995a90a1202
Set id: df110dec-4a50-433a-99ba-4b53bf6a0133
Version: 9
Effective Time: 20230126
 
Premier Brands of America Inc.