ANTI- FUNGAL MICONAZOLE NITRATE- miconazole nitrate 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 Solutions MiconazoleAF Powder - Talc Free

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.

Directions

Other information

Inactive ingredient

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

CORE VALUES

Absorbs Moisture

Miconazorb AF

ANTI-FUNGAL POWDER

Miconazole Nitrate 2%

Cures Most:

Relieves itching, burning, scaling and chafing

Talc-Free

NET WT 2.5 OZ (71 g)

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ANTI- FUNGAL MICONAZOLE NITRATE 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-253
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
ALLANTOIN (UNII: 344S277G0Z)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56104-253-0171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/11/2022
Labeler - Premier Brands of America Inc. (117557458)

Revised: 1/2023
Document Id: f31c3d85-e386-c40b-e053-2a95a90a75a1
Set id: f186bdc1-db6c-0fab-e053-2995a90a7c58
Version: 4
Effective Time: 20230125
 
Premier Brands of America Inc.