Label: ALTRUFUEL HAND SANITIZER- alcohol liquid

  • 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

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 71%

    Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep from fire or flame.

    For external use only

    When using this proudct

    Do not use in or near the eyes, ears or mouth. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor 

    if irritation, redness or rash appears and lasts.

    Keep out of reach of children.

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

  • Directions

    Put enough product in your palm to cover hands and rub hands together briskly until dry. 

    Children should be supervised when using hand sanitizer.

  • Other Information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients

    Water, Triethanolamine, Aloe, Barbadensis Gel, Glycol, Propylene, Glycerin, Carbomer, Vitamin E

  • Package Labeling:75421-001-00

    Bottle

  • Package Labeling:75421-001-01

    Bottle2

  • INGREDIENTS AND APPEARANCE
    ALTRUFUEL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75421-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.71 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE (UNII: V5VD430YW9)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    PROPYLENE (UNII: AUG1H506LY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75421-001-00473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    2NDC:75421-001-013785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/15/2020
    Labeler - Mad Dog Concepts, LLC (079733311)
    Establishment
    NameAddressID/FEIBusiness Operations
    GENERAL ORGANICS INC187576251manufacture(75421-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo BST Clean And Care Products Co., Ltd529352816manufacture(75421-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Gotdya Fine Chemical Co., Ltd.551470189manufacture(75421-001)