BAZA ANTIFUNGAL- miconazole nitrate cream

Baza Antifungal by

Drug Labeling and Warnings

Baza Antifungal by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Perineal
Skin Irritation Due to
Fungal Infection

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

BAZA ANTIFUNGAL 
miconazole nitrate cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COD LIVER OIL (UNII: BBL281NWFG)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LANOLIN (UNII: 7EV65EAW6H)
CETEARETH-6 (UNII: 2RJS3559D3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-045-22	4 g in 1 PACKET; Type 0: Not a Combination Product	06/15/2009
2	NDC: 11701-045-23	57 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009
3	NDC: 11701-045-14	142 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Business Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE(11701-045)