CLOTRIMAZOLE 1%- clotrimazole cream 
Chain Drug Marketing Association Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Quality Choice 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 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

For External Use Only

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

● When using this product avoid contact with eyes.

Stop Use and ask a Doctor if:

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.

Inactive Ingredients

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

Other Information

Questions or Comments?

DISTRIBUTED BY: CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF

Product of PRC

Packaging

clotrimazole cream 1oz

CLOTRIMAZOLE 1% 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-690
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:63868-690-011 in 1 BOX08/13/2020
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/13/2020
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fc8797f1-908b-accb-e053-6294a90a1649
Set id: acc2baee-5762-3239-e053-2995a90ac48c
Version: 3
Effective Time: 20230525
 
Chain Drug Marketing Association Inc.