Baza Antifungal

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-045

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-045
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
BUTYLATED HYDROXYTOLUENE 
COD LIVER OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
LANOLIN 
CETEARETH-6 
STEARYL ALCOHOL 
PROPYLENE GLYCOL 
PEG-100 STEARATE 
ZINC OXIDE 
DIAZOLIDINYL UREA 
WATER 
Packaging
#Item CodePackage Description
1NDC:11701-045-224 g in 1 PACKET
2NDC:11701-045-2357 g in 1 TUBE
3NDC:11701-045-14142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/15/2009
Labeler - Coloplast Manufacturing US, LLC (110326675)
Registrant - Coloplast Corp (847436391)
Establishment
NameAddressID/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-045)

Revised: 06/2012
 
Coloplast Manufacturing US, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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