Label: ATHLETES FOOT- butenafine hydrochloride cream
- NDC Code(s): 36800-049-01
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 15, 2018
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- 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
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for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
Apply between and around the toes
1 week twice a day or 4 weeks once a day - for jock itch and ringworm: 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 - 12 g Tube Carton
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INGREDIENTS AND APPEARANCE
ATHLETES FOOT
butenafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-049 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:36800-049-01 1 in 1 CARTON 12/12/2017 1 12 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 - TOPCO ASSOCIATES LLC (006935977)
