Micro-Guard (AF)

Dosage form: powder
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-038

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.

Micro-Guard® Powder
Antifungal Powder
With Miconazole
Nitrate 2%

For Effective Treatment of Topical Fungal Infections
AF

Drug Facts

Active ingredient

Miconazole Nitrate, 2%

Purpose

Antifungal

Uses Treats jock itch, ringworm, and athlete's foot ►

Warnings

For external use only.

When using this product

  • avoid contact with the eyes
  • if eye contact occurs, flush with water
  • do not use on children under 2 years of age unless directed by a doctor.

Stop using this product

  • for athlete's foot or 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, discontinue use and consult a doctor.

Keep this and all drugs 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 over the 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 condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

Inactive ingredients corn starch USP, sodium bicarbonate, tri-calcium phosphate

Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com Product #1337

©2008-11, Coloplast Corp. Made in the U.SA

PRINCIPAL DISPLAY PANEL - 3 OZ. (85 g)

NDC 11701-038-16

Micro-Guard® Powder
Antifungal Powder
With Miconazole
Nitrate 2%

For Effective Treatment of Topical Fungal Infections

AF

Coloplast

3 OZ. (85 g)

L8-640

MICRO-GUARD   (AF)
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SODIUM BICARBONATE 
TRIBASIC CALCIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:11701-038-1685 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-038)

Revised: 06/2012
 
Coloplast Manufacturing US, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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