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Name:Baza Antifungal
Manufacturer:Coloplast Manufacturing Us, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Baza® AntifungalAntifungalMoisture BarrierAntifungalCream

BAZA ANTIFUNGAL - 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.

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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)

PRINCIPAL DISPLAY PANEL - NET WT. 5 OZ. (142g)

BAZA ANTIFUNGAL  
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC:11701-045-22 4 g in 1 PACKET None
2 NDC:11701-045-23 57 g in 1 TUBE None
3 NDC: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: 06/2010 Coloplast Manufacturing US, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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