Label: GERM SHARK PX7 ANTIBACTERIAL HAND SANITIZER LEMON SCENTED- 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 October 13, 2020

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  • Drug Facts

  • Active Ingredient(s)

    Ethanol Alcohol 70% v/v

    Purpose

    Antiseptic

  • Inactive Ingredients

    Purified water USP, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Aminomethyl Propanol

  • Use(s)

    *Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do Not Use

    • on children less than 2 months of age - supervise use by children
    • on open skin wounds
    • do NOT drink - not for internal consumption

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, 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.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GERM SHARK PX7 ANTIBACTERIAL HAND SANITIZER LEMON SCENTED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75158-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75158-005-013790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2020
    Labeler - Germ Shark, LLC (117480758)
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