FDA Label for Lamisil At Cream

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
OTC - DO NOT USE
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
30 G TUBE WITH CARTON - FOR ATHLETE'S FOOT

Lamisil At Cream Product Label

The following document was submitted to the FDA by the labeler of this product Karo Healthcare 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 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis)
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.

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
- 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 20-25°C (68-77°F)

Inactive Ingredients

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

Questions Or Comments?

call 1-888-544-1880

Carton - carton

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