Label: LAMISIL- terbinafine hydrochloride spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6105-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0067-6293
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 1, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
- When using this product
- Stop use and ask a doctor
- Keep Out of Reach of Children
-
Directions
- adults and children 12 years and over
- wash the affected area with soap and water and dry completely before applying
- to open remove clear cap.
- hold can 4" to 6" from skin. Press and hold to spray a thin layer over affected area
- spray affected area once a day (morning or night) for 1 week or as directed by a doctor
- release to stop spray
- wipe excess from spray opening after each use
- return cap to can
- wash hands after each use
- children under 12 years: ask a doctor
- adults and children 12 years and over
- Other information
- Additional Information
- Inactive ingredients
- Questions
- Principal Display
-
INGREDIENTS AND APPEARANCE
LAMISIL
terbinafine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6105(NDC:0067-6293) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE HYDROCHLORIDE 1.25 mL in 125 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6105-0 125 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021124 04/13/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel