FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ- tolnaftate cream

First Aid Antifungal Medicated Cream 0.5 oz by

Drug Labeling and Warnings

First Aid Antifungal Medicated Cream 0.5 oz by is a Otc medication manufactured, distributed, or labeled by First Aid Reserach Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                                                                        Purpose

Tolnaftate 1%-----------------------------------------------------------------------------------------------Antifungal

PURPOSE

Uses

Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Helps preent most athlete's foot with daily use

for effective relief of itching, burning and cracking

WARNINGS

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

• irritation becomes severe
• there is no improvement within 4 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Directions

• wash affected area and dry throughly
• apply a thin layer over affected area twie daily (morning and night)
• supervise children in the use of this product
• for athlete's foot:pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• use daily for 4 weeks; if condition persists longer, ask a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

OTHER SAFETY INFORMATION

Other information

store between 20° to 25° (68° to 77°F)

Lot No. & Exp. Date;see box or see crimp of tube

INACTIVE INGREDIENT

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

DOSAGE & ADMINISTRATION

Distributed by:

First Aid Research Corp.

Wantagh, NY U.S. A. 11793

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-515-14	1 in 1 CARTON
1		14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/09/2014

Labeler - First Aid Reserach Corp (089405927)