Label: GERM SHARK PX4 HAND JUMBO HAND SANITIZING WIPES- alcohol cloth

  • 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 August 16, 2020

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  • Drug Facts

  • Active Ingredient(s)

    Ethanol Alcohol 80% v/v

    Purpose

    Antiseptic

  • Inactive Ingredients

    Purified water USP 18.425%, Glycerin (glycerol) 1.45%, Hydrogen peroxide 0.125%

    -ingredients shown refer to liquid portion only, not to wipe fabric material

  • Use(s)

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

    -Can be used on hands, arms and legs.

  • Warnings

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

    Use in a well-ventilated area and avoid near sources of ignltion.

    Do Not Use

    • on children less than 2 months of age- supervise use by children
    • on open skin wounds
    • keep out of reach of children and pets
    • for personal hygiene or as a make-up removing wipe
    • as a baby wipe or diaper wipe

    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 redness or rash occurs. for over 72 hours. These may be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • Open box and zipped plastic pouch to thread first wipe (from center of roll) through the hole on top. Don't remove all the wipes.
    • Zip the pouch closed around the wipe. then re-close the box.
    • Gently pull one wipe from the dispenser, pulling at an angle and in a down ward motion.
    • Supervise children under 10 years of age when using this product to avoid swallowing.
    • Let hands completely dry before touching a stove or bbq or coming in close contact with any other open flame.
    • For best results, clean excessively dirty areas before using wipes.
    • Do Not fluh wipes. we recommended that you dispose of them in trash. Flushing wipes can cause damage to plumbing.
  • Other Information

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

    Bottle2

  • INGREDIENTS AND APPEARANCE
    GERM SHARK PX4 HAND JUMBO HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75158-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75158-003-00275 in 1 BOX06/03/2020
    15 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/03/2020
    Labeler - Germ Shark LLC (117480758)
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