Lamisil At Spray
FDA Label NDC 84485-3605

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Karo Healthcare Inc. for the product Lamisil At (NDC 84485-3605). 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, otc - do not use, otc - when using, otc - stop use, otc - 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 1%

Purpose

Antifungal

Uses

  • cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown.
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

Otc - When Using

When using this product

  • do not get into eyes. If eye contact occurs, rinse thoroughly with water.
  • do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120°F (49°C).

Otc - Stop Use

Stop use and ask a doctor if too much irritation occurs or gets worse

Otc - Keep Out Of Reach Of Children

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
    • release to stop spray
    • wipe excess from spray opening after each use
    • return cap to can
      • for athlete’s foot between the toes spray twice a day (morning and night) for 1 week or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • for jock itch and ringworm spray affected area once a day (morning or night) for 1 week or as directed by a doctor
      • wash hands after each use
      • children under 12 years: ask a doctor

Other Information

  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions Or Comments?

call 1-888-544-1880

Package Label.Principal Display

LAMISILAT
SPRAY
TERBINAFINE HYDROCHLORIDE
SOLUTION 1% - ANTIFUNGAL

FOR ATHLETE’S FOOT

RELIEVES ITCHING, BURNING,

CRACKING AND SCALING

THE ONLY 1 WEEK (TWICE A DAY)

ATHLETE’S FOOT SPRAY


►CLINICALLY PROVEN TO CURE MOST ATHLETE’S FOOT BETWEEN THE TOES

► FULL PRESCRIPTION STRENGTH

NET WT 4.20Z (120g)

1-888-544-1880

Distributed By:
Karo Healthcare Inc.
Morristown, NJ 07960 USA

Trademarks owned or Licensed
by Karo Healthcare

©2024 Karo Healthcare or licensor

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Can-label (Image 01)

Can-label (Image 01)

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