Label: JOCK ITCH- butenafine hydrochloride cream
- NDC Code(s): 51672-2101-1, 51672-2101-2, 51672-2101-8, 51672-2101-9
- Packager: Taro Pharmaceuticals U.S.A., inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 20, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- adults and children 12 years and older:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- apply once a day to affected skin for 2 weeks or as directed by a doctor
- wash hands after each use
- children under 12 years: ask a doctor
- adults and children 12 years and older:
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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INGREDIENTS AND APPEARANCE
JOCK ITCH
butenafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Butenafine Hydrochloride (UNII: R8XA2029ZI) (Butenafine - UNII:91Y494NL0X) Butenafine Hydrochloride 10 mg in 1 g Inactive Ingredients Ingredient Name Strength benzyl alcohol (UNII: LKG8494WBH) cetyl alcohol (UNII: 936JST6JCN) glycerin (UNII: PDC6A3C0OX) glyceryl stearate SE (UNII: FCZ5MH785I) ceteth-23 (UNII: 495CTZ441V) propylene glycol dicaprylate (UNII: 581437HWX2) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) stearic acid (UNII: 4ELV7Z65AP) trolamine (UNII: 9O3K93S3TK) petrolatum (UNII: 4T6H12BN9U) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2101-8 1 in 1 CARTON 11/17/2017 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51672-2101-1 1 in 1 CARTON 11/17/2017 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51672-2101-9 1 in 1 CARTON 11/17/2017 3 24 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51672-2101-2 1 in 1 CARTON 11/17/2017 4 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205181 11/17/2017 Labeler - Taro Pharmaceuticals U.S.A., inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2101)