Label: HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 December 2, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient:
    Ethyl alcohol 62%

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    For external use only: hands

    Flammable. Keep away from fire and flame.

  • STOP USE

    Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6, ues only under adult supervision
    • not recommended for infants

  • INACTIVE INGREDIENT

    Inactive ingredients

    acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water

  • OTHER SAFETY INFORMATION

    Other Information

    • do not store above 105F
    • may discolor some fabrics
    • harmful to wood finishes and plastics

  • INDICATIONS & USAGE

    Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use

  • WHEN USING

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-007
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-007-01236.58 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/03/2019
    Labeler - Orazen Inc (080916640)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!