Label: LEADER CLOTRIMAZOLE ANTI-FUNGAL- 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 11, 2016

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  • ACTIVE INGREDIENT

    Active ingredient                                                                    Purpose

    Clotrimazole 1%..................................................................Antifungal

  • PURPOSE

    Uses

    • cures most athletes foot, jock itch, and ringworms
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • WARNINGS

    Warnings For external use only.

  • WHEN USING

    When using this product avoid contact with the eyes

  • DO NOT USE

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

  • 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)
  • 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.

  • INDICATIONS & USAGE

    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
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • Store between 20°C and 25°C (68°F and 77°F)
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    Distributed By Cardinal Health

    Dublin, Ohio 73017

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER CLOTRIMAZOLE ANTI-FUNGAL  
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-760
    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)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-760-101 in 1 CARTON01/11/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/31/2013
    Labeler - Cardinal Health (097537435)
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