Label: LAMISIL AT- terbinafine hydrochloride cream
- NDC Code(s): 0067-8100-12, 0067-8100-15, 0067-8100-30
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 8, 2020
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INGREDIENTS AND APPEARANCE
LAMISIL AT
terbinafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 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:0067-8100-12 1 in 1 CARTON 07/02/2007 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0067-8100-30 1 in 1 CARTON 07/02/2007 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0067-8100-15 1 in 1 CARTON 04/24/2017 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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)