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Name: Baza Antifungal Manufacturer: Coloplast Manufacturing Us, Llc Category: Over-the-counter (OTC) Marketed Drugs
miconazole nitrate cream Coloplast Manufacturing US, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
AntifungalAntifungal Moisture Barrier Antifungal Cream
Skin Irritation Due to Fungal Infection
Miconazole Nitrate, 2%
Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.
When using this product
avoid contact with eyes
do not use on children under 2 years of age unless directed by a doctor.
Stop using this product and ask a doctor if irritation occurs or there is no improvement within 2 weeks.
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
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.
PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142 g)
Moisture Barrier Antifungal Cream
For Perineal Skin Irritation Due to Fungal Infection
NET WT. 5 OZ. (142 g)
miconazole nitrate cream
HUMAN OTC DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
20 mg in 1 g
COD LIVER OIL
.ALPHA.-TOCOPHEROL ACETATE, D-
POLYOXYL 100 STEARATE
4 g in 1 PACKET
57 g in 1 TUBE
142 g in 1 TUBE
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
Labeler - Coloplast Manufacturing US, LLC
Registrant - Coloplast Corp (847436391)
Coloplast Manufacturing US, LLC
Revised: 06/2010 Coloplast Manufacturing US, LLC