ZAPOTOL CLOTRIMAZOLE (CLOTRIMAZOL) CREAM [ZAPOTOL CORP.]

ZAPOTOL CLOTRIMAZOLE (CLOTRIMAZOL) CREAM [ZAPOTOL CORP.]
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NDC 59428-359-28
Set ID 7d5f66e9-12b2-4251-861d-3ed354f76c31
Category HUMAN OTC DRUG LABEL
Packager Zapotol Corp.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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)

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