Micro-guard Powder
FDA Label NDC 11701-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Micro-guard (NDC 11701-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

For Effective Treatment of Topical Fungal Infections
AF

Drug Facts

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.

Otc - Active Ingredient

Active ingredient

Miconazole Nitrate, 2%

Otc - Purpose

Purpose

Antifungal

Indications & Usage

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

Warnings

Warnings

For external use only.

Otc - When Using

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.

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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.

Inactive Ingredient

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

Package Label.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

Figure (Mic01 0003 01)

Figure (Mic01 0003 01)

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