Label: SMARTCARE SHOPKINS- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 27, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses

    To help reduce bacteria and germs on the skin.

  • DOSAGE & ADMINISTRATION

    Directions

    • Place enough product in palm to cove rhands and rub hands briskly together until dry.
    • Children under 6, use only under adult supervision.
    • Not recommended for infants.
  • WARNINGS

    Warning

    Flammable. Keep away from fire or flame. For external use only.

    Stop use and ask a doctor if irritation or redness develops and persists.

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis gel, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    SMARTCARE SHOPKINS 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50154-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50154-010-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product10/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/27/2017
    Labeler - Lantern Enterprises Ltd. (004005196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lantern Science Co., Ltd.421222423manufacture(50154-010)
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