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 August 23, 2010

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  • Clotrimazole

    Active Ingredient

    Clotrimazole 1%

  • PURPOSE

    Purpose

    Antifungal

    Uses

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

    Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    For external use only.

  • INDICATIONS & USAGE

    When using this product avoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

  • PRINCIPAL DISPLAY PANEL

    mage of Clotrimazole Antifungal Cream Carton Label

    mage of Clotrimazole Antifungal Cream Tube Label



  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-103
    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
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-103-011 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)