Label: PURADOR- 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 March 31, 2022

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    • Hand Sanitizer to help reduce bacteria  on the skin.
    • For use when soap and water are not available.
  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame

    When using this product Avoid contact with eyes, ears and mouth. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Apply. Put enough product on hands to cover all surfaces. Rub hands together until feel dry. This should take around 20 seconds.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30 0C (59-86 0F)
    • Avoid freezing and excessive heat above 40 0C (104 0F)
  • Inactive ingredients

    Decolorized Aloe Barbadensis Leaf Juice*, Ammonium Polyacryloyldimethyl Taurate, Tocopheryl Acetate (Vitamin E), Pyrus Malus (Apple)
    Fruit Extract*, Glycerin*, Lavandula Angustifolia (Lavender) Oil**, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Mentha Piperita (Peppermint) Oil*, Eucalyptus Globulus (Eucalyptus) Oil*.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    PURADOR 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69019-002
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    APPLE (UNII: B423VGH5S9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69019-002-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - Vitals Cosmetics International (049656991)
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