Label: PROTECTION HP HAND SANITIZERGEL- hand sanitizergel 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 10, 2020

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  • DOSAGE & ADMINISTRATION

    Store in a cool and dry place

  • INACTIVE INGREDIENT

    Water

  • INDICATIONS & USAGE

    Place enough gel into your palm to thoroughly spread on both hands (front & back) and rub into the skin until dry.Children should be supervised when using this product.

  • ACTIVE INGREDIENT

    carbomer

    triethanolamine

    ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only. Do not use in or near the eyes.In case of contact with eyes, flush thoroughly with water. Do not swallow. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid contact with broken skin. Seek medical help if iritation or redness develops and condition continues for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. Can be used
    on children under adult supervision. Not recommended for infants.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PROTECTION HP HAND SANITIZERGEL 
    hand sanitizergel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54306-004
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.35 g  in 350 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL262.5 mL  in 350 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE1.05 g  in 350 mL
    TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.98 g  in 350 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code PROTECTIONHP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54306-004-01350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2020
    Labeler - Shenzhen Anmay Paper Manufacture Co., Ltd. (543063167)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Anmay Paper Manufacture Co., Ltd.543063167manufacture(54306-004)
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