FDA Label for Baza Antifungal
View Indications, Usage & Precautions
Baza Antifungal 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 Perineal
Skin Irritation Due to
Fungal Infection
Drug Facts
For external use only.
Otc - Active Ingredient
Active ingredient
Miconazole Nitrate, 2%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.
Warnings
Warnings
Otc - When Using
When using this product
- avoid contact with eyes
- do not use on children under 2 years of age unless directed by a doctor.
Otc - Stop Use
Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.
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 thin layer of product over affected area twice daily (morning and night), or as directed by a doctor
- supervise children in the use of this product.
Use daily for 2 weeks.
If condition persists, consult a doctor. This product is not effective on scalp or nails.
Inactive Ingredient
Inactive ingredients
BHT, cetearth-6, cetyl alcohol, cod liver oil, diazolidinyl urea, fragrance, glyceryl stearate, lanolin oil, PEG-100 stearate, petrolatum, polmethoxybicyclic oxazolidine, propylene glycol, water, stearyl alcohol, tocopheryl acetate, zinc oxide
See crimp for lot no. and expiration date
Manufactured by: 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 #1607 ©2008-7, Coloplast Corp.
Made in the U.S.A.
G8-664
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142 g)
NDC 11701-045-14
Baza®Antifungal
Antifungal
Moisture Barrier Antifungal Cream
For Perineal Skin Irritation Due to Fungal Infection
Coloplast
NET WT. 5 OZ. (142 g)
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