Label: INSTANT HAND SANITIZER WITH ALOE 66.5% ETHYL ALCOHOL- ethyl 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 November 8, 2022

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  • ACTIVE INGREDIENTS

    Ethyl Alcohol 66.5%

  • PURPOSE

    Antiseptic

  • USES

    • for handwashing to decrease bacteria on skin without soap and water
    • recommended for repeated use
  • WARNINGS

    For external use only
    Flammable. Keep away from fire or flame
    Do not use in the eyes. If this happens, rinse thoroughly with water.
    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • wet hands and wrists thoroughly with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • INACTIVE INGREDIENTS

    purified water, aloe vera, triethonolamine, carbomer, D&C blue #1, D&C yellow #10, fragrance

  • PRINCIPAL DISPLAY PANEL

    01b LBL_EMS_Instant Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER WITH ALOE  66.5% ETHYL ALCOHOL
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59228-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59228-501-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/18/2022
    Labeler - Ems Acquisition Corp. (048602791)
    Registrant - Ems Acquisition Corp. (048602791)
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