Label: HAND SANITIZER WITH ALOE VERA- 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 July 2, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 62% (V/V)

    Purpose

    Antiseptic

  • Uses

    Hand sanitizer to decrease bacteria on the skin.

  • Warnings

    For external use only -  hands

    Flammable. Keep away from heat or flame.

    When using this product

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

    Stop and ask doctor if

    skin irritation or redness develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping. 
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Do not store above 104° F (40° C).
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients

    Water (Aqua), Glycerin, Aloe barbadensis Leaf Juice, Carbomer, Triethanolamine, Fragrance

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH ALOE VERA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74294-003
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74294-003-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Personal Essential Designs, LLC (080368690)
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