LEADER CLOTRIMAZOLE ANTI-FUNGAL- clotrimazole cream

Leader Clotrimazole Anti-Fungal by

Drug Labeling and Warnings

Leader Clotrimazole Anti-Fungal by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                    Purpose

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

PURPOSE

Uses

• cures most athletes foot, jock itch, and ringworms
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

WARNINGS

Warnings For external use only.

WHEN USING

When using this product avoid contact with the eyes

DO NOT USE

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

STOP USE

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 Poison Control Center right away.

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
• 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 a day
• for athlete's foot and ringworm use daily
• this product is not effective on the scalp or nails

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

DOSAGE & ADMINISTRATION

Distributed By Cardinal Health

Dublin, Ohio 73017

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER CLOTRIMAZOLE ANTI-FUNGAL  
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-760
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-760-10	1 in 1 CARTON	01/11/2016
1		28 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	05/31/2013

Labeler - Cardinal Health (097537435)