Label: LAMISIL AT- terbinafine hydrochloride cream
- NDC Code(s): 0067-3998-30, 0067-3998-42
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 24, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
- When using this product
- Stop use and ask doctor
- Keep out of reach of children
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Directions
• 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
1 week between the toes
• on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
2 weeks on the bottom or sides of the foot
• 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
- Questions or comments?
- Principal display panel
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INGREDIENTS AND APPEARANCE
LAMISIL AT
terbinafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-3998 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 10 mg in 1 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-3998-42 1 in 1 CARTON 08/10/2005 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0067-3998-30 1 in 1 CARTON 08/10/2005 2 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 NDA NDA020980 08/10/2005 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)