Label: MARY JO - CELL CANDY - ADVANCED HAND SANITIZER 80 PERCENT- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 29, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 80% W/V

  • PURPOSE

    ANTISEPTIC

  • USE(S)

    HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

    DO NOT USE

    • IN CHILDREN LESS THAN 2 MONTHS OF AGE
    • ON OPEN SKIN WOUNDS

    WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

  • KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
    • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.
  • OTHER INFORMATION

    • STORE BETWEEN 15-30C (59-86F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)
  • INACTIVE INGREDIENTS

    GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CARBOMER, TOCOPHERYL ACETATE (VIT. E), ANTHEMIS NOBILIS (CHAMOMILE) EXTRACT, TILIA CORDATA (LINDEN) EXTRACT, FRAGRANCE (PARFUM)

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hand-Sanitizer_Mary Jo

  • INGREDIENTS AND APPEARANCE
    MARY JO - CELL CANDY - ADVANCED HAND SANITIZER  80 PERCENT
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75161-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75161-102-11225 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/29/2020
    Labeler - MAREK HEWRYK LLC (033217270)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAREK HEWRYK LLC033217270manufacture(75161-102)
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