Label: ZAPOTOL CLOTRIMAZOLE- clotrimazol 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 13, 2016

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

  • ACTIVE INGREDIENT

    Active ingredient                                                         Purpose

    Clotrimazole 1%--------------------------------------------- Antifungal

  • PURPOSE

    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

  • WHEN USING

    When using this product avoid contact with the eyes

  • ASK DOCTOR

    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 childern

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

  • INDICATIONS & USAGE

    Direction

    • 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 condition persists longer, ask a doctor
    • This product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    Lot No. & Exp. Date;see box or see crimp of the tube

    Store between 20°C to 25°C (68°F to 77°F)

  • 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:

    PRODUCTOS ZAPOTOL CORP.

    Van Nuys, CA 91402

    888-927-6865

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ZAPOTOL CLOTRIMAZOLE 
    clotrimazol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-359
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  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:59428-359-281 in 1 CARTON10/13/2016
    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 finalpart333C08/07/2012
    Labeler - Zapotol Corp. (186063850)