BAZA ANTIFUNGAL - miconazole nitrate cream 
Coloplast Manufacturing US, LLC

----------

Baza® Antifungal
Antifungal
Moisture Barrier
Antifungal
Cream

For Perineal
Skin Irritation Due to
Fungal Infection

Drug Facts

Active ingredient

Miconazole Nitrate, 2%

Purpose

Antifungal

Uses For effective treatment of jock itch. Relieves itching, scaling, irritation, redness and discomfort.

Warnings

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.

For external use only.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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

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)

BAZA ANTIFUNGAL   miconazole nitrate   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11701-045 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg  in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM   CETYL ALCOHOL   GLYCERYL MONOSTEARATE   BUTYLATED HYDROXYTOLUENE   COD LIVER OIL   .ALPHA.-TOCOPHEROL ACETATE, D-   LANOLIN   STEARYL ALCOHOL   PROPYLENE GLYCOL   POLYOXYL 100 STEARATE   ZINC OXIDE   DIAZOLIDINYL UREA   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11701-045-22 4 g In 1 PACKET None 2 11701-045-23 57 g In 1 TUBE None 3 11701-045-14 142 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE

Revised: 06/2010Coloplast Manufacturing US, LLC