NDC | 37808-013-02 |
Set ID | 0841f741-6409-4d93-a6a7-901808f77bcd |
Category | HUMAN OTC DRUG LABEL |
Packager | H E B |
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 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?
- PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
-
INGREDIENTS AND APPEARANCE
ATHLETES FOOT ULTRA
butenafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-013 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:37808-013-02 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 - H E B (007924756)