Label: PURAGO 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 June 2, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 75%

    Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease 
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable, keep away from fire or flame. 

    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

    Stop use and ask a doctor if

    • irritation and redness develop 
    • condition persist for more than 72 hours

    Keep out of reach of children.

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

  • Directions

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

    Water, Aloe Barbadensis Leaf Extract, Acrylate/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine

  • Other Information

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

    Label5

  • INGREDIENTS AND APPEARANCE
    PURAGO HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76812-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76812-009-00250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/10/2020
    Labeler - Puraall LLC (117497553)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD542355899manufacture(76812-009)
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