Label: SILKA ANTIFUNGAL- terbinafine hydrochloride cream
- NDC Code(s): 50066-080-02, 50066-080-03, 50066-080-05
- Packager: Genomma Lab USA, Inc.
- Category: HUMAN OTC DRUG LABEL
Updated September 15, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
- adults and children 12 years and over
- 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 wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
- for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
- wash hands after each use.
- children under 12 years: ask a doctor.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
INGREDIENTS AND APPEARANCE
terbinafine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine 1 g in 100 g Inactive Ingredients Ingredient Name Strength benzyl alcohol (UNII: LKG8494WBH) cetyl alcohol (UNII: 936JST6JCN) cetyl palmitate (UNII: 5ZA2S6B08X) isopropyl myristate (UNII: 0RE8K4LNJS) polysorbate 60 (UNII: CAL22UVI4M) water (UNII: 059QF0KO0R) sodium hydroxide (UNII: 55X04QC32I) sorbitan monostearate (UNII: NVZ4I0H58X) stearyl alcohol (UNII: 2KR89I4H1Y) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-080-02 1 in 1 CARTON 07/02/2007 1 30 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:50066-080-03 1 in 1 CARTON 05/21/2018 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:50066-080-05 1 in 1 CARTON 12/20/2018 3 15 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 ANDA077511 07/02/2007 Labeler - Genomma Lab USA, Inc. (832323534) Registrant - Taro Pharmaceuticals U.S. A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(50066-080)