Label: BIOPROTECT HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT- isopropyl alcohol spray

  • 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 19, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT(S)

    Isopropyl Alcohol 75% v/v

    PURPOSE

    Antiseptic

  • 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
    • on open skin wounds

    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.

  • OTHER INFORMATION

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

  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • 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.

  • Package Labeling:

    Bottle2

  • INGREDIENTS AND APPEARANCE
    BIOPROTECT HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 75 PERCENT 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79141-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79141-002-00236 mL in 1 CAN; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Global BioProtect, LLC (080387141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vin Mar Industries LLC114772616manufacture(79141-002) , pack(79141-002)
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