Label: INSTANT HAND SANITIZER ALOE VERA- ethyl alcohol liquid

  • 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 December 26, 2014

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol  70% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use

    • Hand sanitizer to help reduce bacteria on the skin.
  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.
    • Children under 6 years of age should be supervised when using this product.
  • SPL UNCLASSIFIED SECTION

    Other information

    • Store below 106°F (41°C).
    • May discolor certain fabrics or surfaces.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, glycerin, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, isopropyl alcohol, aminomethyl propanol,  isopropyl myristate,  caprylyl glycol, phenoxyethanol, fragrance, tocopheryl acetate, aloe barbadensis gel, FD&C yellow no.5, FD&C blue no.1.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    INSTANT HAND SANITIZER ALOE VERA WITH VITAMIN E AND OTHER MOISTURIZERS

    ANTIMICROBIAL

    KILLS GERMS WITHOUT WATER

    8 FL.OZ (236 mL)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER ALOE VERA 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-016-2959 mL in 1 BOTTLE, PLASTIC
    2NDC:52000-016-01118 mL in 1 BOTTLE, PLASTIC
    3NDC:52000-016-30236 mL in 1 BOTTLE, PLASTIC
    4NDC:52000-016-31295 mL in 1 BOTTLE, PLASTIC
    5NDC:52000-016-32354 mL in 1 BOTTLE, PLASTIC
    6NDC:52000-016-33472 mL in 1 BOTTLE, PLASTIC
    7NDC:52000-016-34708 mL in 1 BOTTLE, PLASTIC
    8NDC:52000-016-35944 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/22/2014
    Labeler - Universal Distribution Center LLC (019180459)