Label: BAZA ANTIFUNGAL- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11701-045-14, 11701-045-22, 11701-045-23 - Packager: Coloplast Manufacturing US, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 14, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
Drug Facts
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.
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
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INGREDIENTS AND APPEARANCE
BAZA ANTIFUNGAL
miconazole nitrate creamProduct 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)
