FDA Label for Micro-guard (af)
View Indications, Usage & Precautions
Micro-guard (af) Product Label
The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- use daily for 4 weeks
- use daily for 2 weeks
For athlete's foot and ringworm
For jock itch
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
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