Label: LAMISIL AT CREAM- terbinafine hydrochloride cream
- NDC Code(s): 61047-120-01, 61047-120-02, 61047-120-03
- Packager: KIK HOLDCO COMPANY INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 4, 2020
If you are a consumer or patient please visit this version.
- 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
- Questions or comments?
- 12 g Tube with Carton - For Jock Itch
- 12 g Tube with Carton - For Athlete's Foot
- 30 g Tube with Carton - For Athlete's Foot
INGREDIENTS AND APPEARANCE
LAMISIL AT CREAM
terbinafine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61047-120 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 CETYL ALCOHOL (UNII: 936JST6JCN) POLYSORBATE 60 (UNII: CAL22UVI4M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL PALMITATE (UNII: 5ZA2S6B08X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61047-120-01 1 in 1 CARTON 02/24/2020 1 12 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:61047-120-02 1 in 1 CARTON 03/02/2020 2 12 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:61047-120-03 1 in 1 CARTON 02/20/2020 3 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 02/20/2020 Labeler - KIK HOLDCO COMPANY INC. (243547333) Establishment Name Address ID/FEI Business Operations KIK HOLDCO COMPANY INC. 243547333 manufacture(61047-120)