Label: TERBINAFINE HYDROCHLORIDE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51672-2083-8 - Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 29, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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
- 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
- adults and children 12 years and over:
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
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INGREDIENTS AND APPEARANCE
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2083 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:51672-2083-8 1 in 1 CARTON 07/02/2007 1 12 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 - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2083)