NDC | 51672-2100-1, 51672-2100-2, 51672-2100-8, 51672-2100-9 |
Set ID | 4b400be5-acaa-4a5f-b8ef-c0df8ad6175f |
Category | HUMAN OTC DRUG LABEL |
Packager | Taro Pharmaceuticals U.S.A., inc. |
Generic Name | |
Product Class | Benzylamine Antifungal |
Product Number | |
Application Number | ANDA205181 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
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
-
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 toes1 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 - 15 g Tube Carton
-
INGREDIENTS AND APPEARANCE
ATHLETES FOOT
butenafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2100 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) 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:51672-2100-8 1 in 1 CARTON 11/17/2017 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51672-2100-1 1 in 1 CARTON 11/17/2017 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51672-2100-9 1 in 1 CARTON 11/17/2017 3 24 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51672-2100-2 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(51672-2100)