Label: 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 December 4, 2013

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  • 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

    • on children under 2 years of age except under the advice and supervision of a doctor

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    • Irritation occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash

    Keep out of reach of children

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

  • Directions

    • Wash 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
    • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
    • If conditions persist longer, ask a doctor
    • This product is not effective on the scalp or nails
  • Other information

    • store between 2°and 30°C (36°and 86°F)

  • Inactive ingredients

    Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

  • PRINCIPAL DISPLAY PANEL

    Clotrimazole

    image of carton label

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0022
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0022-11 in 1 BOX
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/04/2013
    Labeler - Promex, LLC (789974388)
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