CLOTRIMAZOLE- clotrimazole cream 
Proficient Rx LP

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Clotrimazole cream USP, 1%

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

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.

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

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

● For external use only

● Avoid contact with eyes.

● If irritation occurs or if there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

Directions

Wash the affected area and dry thoroughly.

● 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. 

Inactive Ingredients

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Other Information

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

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

Relabeled By: Proficient Rx LP
Thousand Oaks, CA 91320

Packaging

71205-434-05
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-434(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
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LAURETH-23 (UNII: N72LMW566G)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-434-051 in 1 BOX03/18/2020
114.2 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 - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-434) , RELABEL(71205-434)

Revised: 11/2023
Document Id: fa8aeb26-bd17-471f-aa37-827321613599
Set id: 800a9dab-d287-427e-af6d-26996e0def41
Version: 3
Effective Time: 20231101
 
Proficient Rx LP