Label: TM-CLOTRIMAZOLE- clotrimazole 1% cream

  • NDC Code(s): 83035-1062-3
  • Packager: Singular Dreamer, Ltd dba True Marker
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 10, 2023

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  • Active ingredients

    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 – 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
      ● Irritation occurs
      ● There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
    • Keep out of 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

    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

  • INGREDIENTS AND APPEARANCE
    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)