Label: AMORAY PREMIUM HAND SANITIZER- 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 14, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    •Hand sanitizer to help decrease bacteria on the skin. •When water, soap & towel are not available. •Recommended for repeated use.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes.

    Do not use

    in ears & mouth.

    When using this product,

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if

    redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    •Pump as needed into your palms and thoroughly spread on both hands. •Rub into skin until dry.

  • Other information

    •Store at 20°C (68 to 77°F).•May discolor fabrics.

  • Inactive ingredients

    •Water, triethanolamine, glycerin, carbomer, PEG-40 hydrogenated castor oil, propylene glycol, fragrance, tocopheryl acetate, aloe barbadensis gel.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    AMORAY PREMIUM HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-4221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-4221-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/29/2020
    Labeler - My Imports USA LLC (195767988)
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