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Micro-Guard

Coloplast Manufacturing US, LLC
Coloplast Corp

Antifungal PowderWith MiconazoleNitrate 2%




FULL PRESCRIBING INFORMATION

For Effective Treatment of Topical Fungal Infections
AF

Drug Facts

Active ingredient

Active ingredient

Miconazole Nitrate, 2%

Purpose

Purpose

Antifungal

Uses

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

Miconazole Nitrate POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11701-038
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
SODIUM BICARBONATE
TRIBASIC CALCIUM PHOSPHATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11701-038-16 85 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2009-06-15


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