MICRO-GUARD (AF)- miconazole nitrate powder

Micro-Guard by

Drug Labeling and Warnings

Micro-Guard by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Effective Treatment of Topical Fungal Infections
AF

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

MICRO-GUARD   (AF)
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11701-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-038-16	85 g in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-038)