MICRO-GUARD  (AF)- miconazole nitrate powder 
Coloplast Manufacturing US, LLC

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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

Figure
MICRO-GUARD   (AF)
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11701-038-1685 g in 1 BOTTLE; Type 0: Not a Combination Product06/15/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00506/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIBusiness Operations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-038)

Revised: 12/2023
Document Id: a7737468-09a2-4153-a3a5-b60c2cf9676c
Set id: a43a94d0-fec0-470f-bdb4-535dcce6d1e0
Version: 7
Effective Time: 20231214
 
Coloplast Manufacturing US, LLC