Label: AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ORIGINAL- alcohol solution

  • 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 April 24, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on the skin

    When water, soap, and towel are not available

    Recommended for repeaded use

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame

  • WHEN USING

    Do not apply around eyes

    Do not use in ears and mouth

    When using this product avoid contact with eyes. In case of contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Directions

    Wet hands thoroughly with products and rub into skin until dry

  • Other information

    Store at 20C (68-77F)

    May discolor fabrics

  • Inactive ingredients

    Water, triethanolamine, carbomer, aloe barbadensis gel, fragrance, glycerin, propylene glycol, tocopheryl acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ORIGINAL 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76114-005
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76114-005-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Zhejiang Aidi Cosmetics Co., Ltd (530876820)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd530876820manufacture(76114-005)
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