CLOTRIMAZOLE CREAM, 1%- clotrimazole cream

Clotrimazole Cream, 1% by

Drug Labeling and Warnings

Clotrimazole Cream, 1% by is a Otc medication manufactured, distributed, or labeled by Estiva Generics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Clotrimazole USP 1% w/w

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 use onchildren under 2 years of age unless directed by a doctor. 
• When using this productavoid contact with eyes. 
• Stop use and ask a doctor if 
• Irritation occurs 
• There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch). 
• 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 right away.

KEEP OUT OF REACH OF CHILDREN

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 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 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 (59° - 86°F)
• Close cap tightly after use.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Cetyl Esters, Curcuma Longa (Turmeric)
Root Extract, Ethylhexyl Palmitate, Ethylhexylglycerin, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Sorbitan Stearate,Tocopheryl Acetate, Triethanolamine, Water (Aqua)

SPL UNCLASSIFIED SECTION

Questions?844-966-7265

Product label

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE CREAM, 1% 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85633-004
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
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
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: 85633-004-01	30 g in 1 TUBE; Type 0: Not a Combination Product	05/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/19/2025

Labeler - Estiva Generics Corporation (119497561)