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Lamisil

Dosage form: spray
Ingredients: TERBINAFINE HYDROCHLORIDE 1.25mL in 125mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-6105

Drug Facts

Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses
  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

For external use only

Do Not Use
  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

if too much irritation occurs or gets worse.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control

Center right away.  

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

Other information

store at 8° - 25° C (46° - 77° F)

Additional Information

Full Prescription Strength

Continuous Spray Action

Cures Most Jock Itch

For Effective Relief of Itching & Burning

Distr. By:  

 
Novartis Consumer Health, Inc.
 
Parsippany, NJ 07054-0622 ©2009

Inactive ingredients

Ethanol, polyoxyl 20 cetostearyl ether, propylene glycol, purified water

Questions

call 1-800-452-0051 or visit us at www.lamisilat.com

Principal DisplayRelabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

NDC 54868-6105-0

LAMISIL 
terbinafine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6105(NDC:0067-6293)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE1.25 mL  in 125 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:54868-6105-0125 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02112404/13/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 01/2010
 
Physicians Total Care, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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