FIRST AID RESEARCH ANTIFUNGAL .5OZ- clotrimazole cream

First Aid Research Antifungal .5oz by

Drug Labeling and Warnings

First Aid Research Antifungal .5oz by is a Otc medication manufactured, distributed, or labeled by First Aid Research Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                  Purpose

Clotrimazole 1%................................................ Antifungal

PURPOSE

Uses

• cures most athlete's foot, jock itch, and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on children under 2 years of age unless directed by a doctor.

WHEN USING

When using this product avoid contact with the eyes

ASK DOCTOR

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice 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
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition persists longer, ask a doctor
• this prodcuct is not effective on the scalp of nails

STORAGE AND HANDLING

Other information

• store between 20° to 25°C (68° to 77°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

2-octyldodecanol, benzyl alcohol, cetearyl alcohol, cetyl esters, monobasic sodium phosphate dihydrate, polysorbate 60, propylene glycol, purified water, sorbitan stearate

DOSAGE & ADMINISTRATION

Distributed by:

First Aid Research Corp.

Wantagh, NY 1793 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID RESEARCH ANTIFUNGAL .5OZ 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ESTERS WAX (UNII: D072FFP9GU)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PEG-60 SORBITAN STEARATE (UNII: 073G38N8GC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-420-14	1 in 1 CARTON
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/14/2014

Labeler - First Aid Research Corp. (089405927)