MICONAZOLE NITRATE- anti-fungal powder miconazole nitrate powder 
Topco Associates LLC

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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Anti - Fungal 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 under 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 ingredients

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

Questions?

Call 1-888-423-0139

Principal Display Panel

TopCare

ANTIFUNGAL POWDER

MiconasorbAF

Miconazole Nitrate 2%

COMPARE TO ZEASORB active ingredients

NET WT 2.5 OZ (71g)

Topcare Miconazorb AF Powder LABEL.jpg

MICONAZOLE NITRATE 
anti-fungal powder miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-071
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)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-071-2571 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2016
Labeler - Topco Associates LLC (006935977)

Revised: 1/2016
Document Id: 9e12cded-f09c-46a8-a617-49dfeab2d02a
Set id: 7ac90517-7d9b-4d94-b1c9-b424ad907a59
Version: 1
Effective Time: 20160120
 
Topco Associates LLC