CLOTRIMAZOLE- clotrimazole cream 
TRIFECTA PHARMACEUTICALS USA LLC

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Clotrimazole cream USP, 1%

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

Uses

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

Warnings

For External use only.

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.

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

Keep this and all drugs out of the reach of children

In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away.

Directions

● Apply a thin layer of this 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 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

Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

Questions?

Adverse drug event call 1-888-296-9067

Dist. By Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

4010 GLOBE CLOTRIMAZOLE CREAM 1OZ LONG HANGING REV06 011023 CDER

4315 GLOBE CLOTRIMAZOLE CREAM 4OZ 081523 CDER

4020-FBA-1 GLOBE CLOTRIMAZOLE CREAM 1OZ 5PK BOX 101323 CDER

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-001-555 in 1 BOX11/06/2023
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-001-051 in 1 BOX08/23/2016
215 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:69396-001-09144 in 1 BOX03/09/2022
30.9 g in 1 PACKAGE; Type 0: Not a Combination Product
4NDC:69396-001-041 in 1 BOX05/03/2022
4113.4 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:69396-001-201 in 1 BOX03/10/2015
528.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/10/2015
Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 11/2023
Document Id: 09d3c52c-988e-eb94-e063-6394a90ae298
Set id: 6b74d405-42d6-4c46-ba78-3007d1e8ffb8
Version: 20
Effective Time: 20231110
 
TRIFECTA PHARMACEUTICALS USA LLC