Label: HAND SANITIZER- 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 May 26, 2020

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  • Drug Facts:

  • ACTIVE INGREDIENT

    Medicinal Ingredient: Ethyl Alcohol 70%

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

  • Directions:

    Put a thumbnail size amount in your palm and rub hands briskly until dry.

    Note:

    Children under 6 years of age should be supervised during use.

  • STORAGE AND HANDLING

    Do not store above 105°C. May discolor certain fabrics.

  • Caution:

    Flammable. Keep away from fire or flame. For external use only. Keep out of eyes. In case of eye contact, immediately flush with water. If swallowed, call a physician. Discontinue use if irritation or redness develop. If condition persists for more than 72 hours, consult a physician.

    KEEP OUT OF REACH OF CHILDREN.

  • INGREDIENTS:

    Alcohol (70%), Water(Aqua), Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Parfum.

    MAY CONTAIN.

    Yellow 5 Lake(CI 19140), Red 34 (CI 15880), Red 6 Lake(CI 15850), Ferric Ferrocyanide (CI 77510).

  • SPL UNCLASSIFIED SECTION

    Aloe & Vitamin E

    Kill 99.9% of Germs

    Formulated & developed in USA

    Distributed by:

    L.E.D COSMETICS INC.

    Diamond Bar, CA, USA. 91765

    Made in China

    cruelty free Not tested on animals

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77725-002
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 34 (UNII: BAN556989E)  
    D&C RED NO. 6 BARIUM LAKE (UNII: K4XZD9W99K)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77725-002-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/26/2020
    Labeler - L.E.D. Cosmetics, Inc. (093000774)
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