ANTIFUNGAL- clotrimazole cream

ANTIFUNGAL by

Drug Labeling and Warnings

ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Encube Ethicals, Inc., Encube Ethicals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Clotrimazole, USP 1% 

PURPOSE

Antifungal

USE(S)

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

WARNINGS

For external use only.

DO NOT USE

on children under 2 years of age, unless directed by a doctor.

WHEN USING THIS PRODUCT

avoid contact with the eyes.

STOP USE AND ASK DOCTOR IF

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

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

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

OTHER INFORMATION

• store at room temperature 20°C to 25°C (68°F to 77°F)
• before using any medication, read all label directions. Keep carton, It contains important information.

INACTIVE INGREDIENTS

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

QUESTIONS OR COMMENTS?

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 0.5 OZ (14 g)

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21922-094
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETYL ESTERS WAX (UNII: D072FFP9GU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21922-094-04	1 in 1 CARTON	03/06/2025
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 21922-094-05	1 in 1 CARTON	03/06/2025
2		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 Drug	M005	03/06/2025

Labeler - Encube Ethicals, Inc. (116982244)

Registrant - Encube Ethicals Private Limited (915834105)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	analysis(21922-094) , label(21922-094) , manufacture(21922-094) , pack(21922-094)