Miconazole Nitrate by AmerisourceBergen Drug Corporation GNP Miconazorb AF Powder

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen Drug Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MICONAZOLE NITRATE- miconazorb af antifungal powder powder 
AmerisourceBergen Drug Corporation

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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GNP 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

GOOD NEIGHBOR PHARMACY

MiconazorbAF

Miconazole Nitrate 2%

ANTIFUNGAL POWDER

• Cures and soothes most athlete's foot, jock itch and ringworm
• Moisture absorbing
• Soothes chafing

NET WT 2.5 OZ (71 g)

MICONAZOLE NITRATE 
miconazorb af antifungal powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	1.42 g  in 71 g

Inactive Ingredients
Ingredient Name	Strength
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-039-27	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/10/2012	12/31/2019

Labeler - AmerisourceBergen Drug Corporation (007914906)

Revised: 12/2019

Document Id: 98cfaed7-5b7a-2341-e053-2a95a90a818b

34390-5

Set id: a8a76919-4104-494b-8e5b-4511367c8b6e

Version: 3

Effective Time: 20191203

 

AmerisourceBergen Drug Corporation