Label: CLOTRIMAZOLE cream

  • Category: HUMAN OTC DRUG LABEL

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 July 29, 2014

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  • Drug Facts

    Active Ingredient:             Purpose

    Clotrimazole 1%            Antifungal

  • Uses

    Treats most athlet's foot, jock itch and ringworm, relieves itching, scaling, burning, irritation, and discomfort

  • Directions

    Clean 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 products.This products does not work on the scalp or nail. For athlet's foot and ringworm pay special attention to spaces between the toes: wear well fitting, ventilates shoes, and change shoes and socks at least once every day. Use every day for 4 weeks. For jock itch, use every day for 2 weeks. If condition lasts longer, contact a doctor.

  • Warnings

    FOR EXTERNAL USE ONLY

    When using this product do not get in to the eyes. Stop use and ask doctor if irritation occurs there is no improvement within 4 weeks (for athlet's foot or ringworm) or within 2 weeks (for jock itch). Do not use on children under 2 years, unless directed by a doctor.

  • Inactive Ingredients

    Benzyl alcohol, Cetearth 20, Cetyl alcohol, Citric acid, Paraffin wax, Petrolatum, Polysorbate 80, Sodium citrate, Sorbitan sesquioleate, Stearyl alcohol, Water

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    In the event of accidental ingestion, contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Store between 20'-30'C (36'-86'F)

  • DOSAGE & ADMINISTRATION

    Use every day for 4 weeks. For jock itch, use every day for 2 weeks. if conditon lasts longer, contact a doctor

  • PRINCIPAL DISPLAY PANEL

    Label of tube

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-018
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-018-0514 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/29/2014
    Labeler - Geritrex Corp (112796248)
    Registrant - Geritrex Corp (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex Corp112796248manufacture(54162-018)
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