Label: CLOTRIMAZOLE- drs. clotrimazole cream

  • 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 October 2, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Clotrimazole 1%

  • PURPOSE

    Antifungal

  • USES

    • cures most athlete's foot, jock itch and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • warnings

    For external use only

  • Do not use:

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

  • WHEN USING THIS PRODUCT

    avoid contact with the eyes

  • Stop use and ask your doctor if:

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • wash the affected area and dry thoroughly
    • apply a thin layer of the 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 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 lasts longer, contact a doctor

    • this product is not effective on the scalp or nails
  • Other information

    • store at controlled room temperature 59°-86°F (15°-30°C).
    • before using any medication, read all label directions. Keep carton, it contains important information
  • Inactive ingredients

    sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water

  • For Questions:

    www.drspharmacyusa.com

  • PRINCIPAL DISPLAY PANEL

    original strenghth

    Antifungal cream

    clotrimazole

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    drs. clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-002-011 in 1 CARTON01/01/2021
    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 finalpart333C01/01/2021
    Labeler - OL PHARMA TECH,LLC (021170377)
    Registrant - OL PHARMA TECH,LLC (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH,LLC (Drs, pharmacy)021170377manufacture(80489-002)