TM-CLOTRIMAZOLE- clotrimazole 1% cream 
Singular Dreamer, Ltd dba True Marker

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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Active ingredients

Clotrimazole USP 1% w/w

Purpose

Antifungal

Uses

Warnings

Directions

Other information

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.

Questions?

304-742-2433

Product label

image description

TM-CLOTRIMAZOLE 
clotrimazole 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83035-1062
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83035-1062-31 in 1 CARTON04/03/2023
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/03/2023
Labeler - Singular Dreamer, Ltd dba True Marker (129504103)
Registrant - Singular Dreamer, Ltd dba True Marker (129504103)

Revised: 4/2023
Document Id: f8ffe76d-f801-24eb-e053-6394a90a9b0e
Set id: d6a9755a-9ed1-4e7d-8e73-25c169d6c6b1
Version: 2
Effective Time: 20230410
 
Singular Dreamer, Ltd dba True Marker