Lamisil At Cream
FDA Label NDC 84485-3607

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 Cream (NDC 84485-3607). 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 jock itch (tinea cruris)
  • 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.

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:
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • apply 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

  • do no use if seal on tube is broken or is not visible
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions Or Comments?

call 1-888-544-1880

12 G Tube With Carton - For Jock Itch

LAMISILAT
CREAM

TERBINAFINE HYDROCHLORIDE
CREAM 1% - ANTIFUNGAL

for JOCK ITCH

► CURES MOST JOCK ITCH
► FOR EFFECTIVE RELIEF OF ITCHING AND BURNING

NET WT 12 g (0.42 oz)

RECYCLABLE CARTON

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

Made in Canada

Trademarks owned or
licensed by Karo Healthcare

©2024 Karo Healthcare
or licensor.

Karo
healthcare

Questions or
comments?
call 1-888-544-1880

NDC
84485-3607-1
2004313_1

Carton (Carton1)

Carton (Carton1)

2004314_1

Tube (Tube)

Tube (Tube)

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