Label: PUROX 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 July 8, 2020

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  • Active Ingredient

    Alcohol 85% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from heat or flame

    For external use only

  • WHEN USING

    When using this product

    • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
  • STOP USE

    Stop use and ask a doctor if

    • irritation or rash appears and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • Directions

    • Place enough product in your palm to thoroughly spread on both hands and rub into th skin until dry.
    • Children under 6 years old should be supervised when using this product.
  • Other information:

    • store between 106F (41C)
    • may discolor certain fabrics or surfaces
  • Inactive ingredients:

    Deionized Water, Aloe, Triethanolamine, Carbomer

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    PUROX HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78186-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9) 0.05 L  in 100 L
    TROLAMINE (UNII: 9O3K93S3TK) 0.03 L  in 100 L
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 1.45 L  in 100 L
    WATER (UNII: 059QF0KO0R) 13.47 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78186-001-020.384 L in 1 BOTTLE; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Purox (121224718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purox121224718manufacture(78186-001)
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