Clotrimazole by Cardinal Health 110 dba LEADER / Trifecta Pharmaceuticals USA CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110 dba LEADER, Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole USP 1%

Purpose

Antifungal Cream

Uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings

For External use only.

Keep this and all drugs out of the reach of children

Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

Do Not Use

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

When using this product

When using this product avoid contact with eyes

Stop use and ask doctor if

• irritaion occurs
• There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Directions

• Wash the affected area and dry thoroughly.

● Apply a thin layer oover 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 the 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 conditions persists longer, consult a doctor.

● This product is not effective on the scalp or nails.

Other Information

• store at controlled room temperature 15°-30°C (59°- 86°F)
• Close cap tightly after use.

Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerol, Polyoxyethylene lauryl ether, Mineral Oil, Petrolatum, Water, alcohol, Mono and di-glycerides, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

Questions?

Adverse drug event call 1-888-296-9067

Distributed by Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

* This product is not manufactured or distributed by Schering-Plough, Inc., the distributor of Lotrimin®AF.

©2024 Cardinal Health. All rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

CIN 5888649

Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0667
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
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-23 (UNII: N72LMW566G)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0667-2	1 in 1 BOX	05/10/2024
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70000-0667-1	1 in 1 BOX	05/10/2024
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	05/10/2024

Labeler - Cardinal Health 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA (079424163)