LAMISILAT  - terbinafine hydrochloride spray 
Physicians Total Care, Inc.

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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 Display

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

NDC 54868-6105-0

LAMISILAT  terbinafine hydrochloride   spray

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54868-6105 (0067-6293) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 1.25 mL  in 125 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   POLYOXYL 20 CETOSTEARYL ETHER   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54868-6105-0 125 mL In 1 BOTTLE, SPRAY None

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	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 01/2010Physicians Total Care, Inc.