FDA Label for Lamisil

View Indications, Usage & Precautions

Lamisil Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.