Otc - Active Ingredient
Terbinafine hydrochloride 1%
Lamisil At Terbinafine Hydrochloride Cream
FDA Label NDC 61047-139
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Voyant Beauty, Inc. for the product Lamisil At Terbinafine Hydrochloride (NDC 61047-139). 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 otc - active ingredient, otc - purpose, indications & usage, 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
Otc - Purpose
Antifungal
Indications & Usage
- cures most athlete's foot (tinea pedis)
- cure most jock itch (tinea cruris) and ringworm (tinea corporis)
- relieves itching, burning, cracking andf scaling which accompany this condition
Warnings
For external use only
Otc - Do Not Use
- on nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
do not get into eyes. If eye contact occurs, rinse thoroughly with water
Otc - Stop Use
ask a doctor if too much irritation occurs or gets worse
Otc - 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
- for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
- for jock itch and ringworm: 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 20-25C (68-77F)
Inactive Ingredient
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearly alcohol
Otc - Questions
call 1-888-544-1880
Package Label.Principal Display Panel
Lamisil AT Cream
Terbinafine Hydrochloride Cream 1% - Antifungal
For Athlete's Foot
NET WT 30 g (1 oz)
* Please review the disclaimer below.
