Baza Antifungal (Miconazole Nitrate) Cream [Coloplast Manufacturing Us, Llc] -

BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]
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NDC	11701-045-14, 11701-045-22, 11701-045-23
Set ID	75182cb7-840a-423a-9c20-10840d6e1d65
Category	HUMAN OTC DRUG LABEL
Packager	Coloplast Manufacturing US, LLC
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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