Label: LAMISIL AT TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream
- NDC Code(s): 61047-139-01
- Packager: Voyant Beauty, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 16, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- 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 INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LAMISIL AT TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61047-139 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 SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM HYDROXIDE (UNII: 55X04QC32I) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CETYL PALMITATE (UNII: 5ZA2S6B08X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61047-139-01 1 in 1 CARTON 08/21/2024 1 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 08/21/2024 Labeler - Voyant Beauty, Inc. (243547333)