Lamisil
FDA Label NDC 54868-6105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Lamisil (NDC 54868-6105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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