Clotrimazole Cream, 1% by Pharmaceutica North America, Inc / Pure Source, LLC

Clotrimazole Cream, 1% by

Drug Labeling and Warnings

Clotrimazole Cream, 1% by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLOTRIMAZOLE CREAM, 1%- clotrimazole cream 
Pharmaceutica North America, Inc

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Active Ingredient

Clotrimazole USP 1%

Purpose

Antifungal

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

• For external use only. 
• Do not useon children under 2 years of age unless directed by a doctor. 
• When using this product, avoid contact with eyes. 
• Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
• Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions

Wash the 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 athletes' 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 athletes foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
If condition 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 (50 – 86F)
Close cap tightly after use.

Inactive Ingredients

Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water

Product label

CLOTRIMAZOLE CREAM, 1% 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-099
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERETH-31 (UNII: 11L9WC241B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-099-07	29 g in 1 TUBE; Type 0: Not a Combination Product	12/10/2024	11/01/2025
2	NDC: 45861-099-08	2 in 1 CARTON	02/07/2025	02/07/2025
2		58 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 45861-099-09	2 in 1 CARTON	02/07/2025	11/01/2025
3		29 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	12/10/2024	12/31/2025

Labeler - Pharmaceutica North America, Inc (962739699)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(45861-099)

Revised: 12/2025

Document Id: 471c0796-7da6-3947-e063-6394a90ab3b6

34390-5

Set id: 0085f818-ae14-470a-a0ae-b91e224d1362

Version: 6

Effective Time: 20251229