Micro-guard

Micro-guard
SPL v7
SPL
SPL Set ID a43a94d0-fec0-470f-bdb4-535dcce6d1e0
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Starch, Corn Sodium Bicarbonate Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-06-15

Description

For Effective Treatment of Topical Fungal Infections AF


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

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

Dosage and 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.
Description

For Effective Treatment of Topical Fungal Infections AF

Section 42229-5

For Effective Treatment of Topical Fungal Infections

AF

Section 50565-1

Keep this and all drugs out of reach of children.

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

Section 50566-9

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.
Section 50567-7

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.
Section 51727-6

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

Section 51945-4

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

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Miconazole Nitrate, 2%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

For Effective Treatment of Topical Fungal Infections

AF

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children.

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

Section 50566-9 (50566-9)

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.
Section 50567-7 (50567-7)

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.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Miconazole Nitrate, 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)