Available Formats

• SPL UNCLASSIFIED SECTION

  For Perineal
  Skin Irritation Due to
  Fungal Infection

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• 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

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• 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)

  

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• 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)

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