Label: AFFEX CARE HAND SANITIZER- alcohol 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 December 6, 2021

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Flammable. Keep away from heat or flame

    For external use only.

  • INSTRUCTIONS FOR USE

    place enough product in your palm to thoroughly cover your hands
    rub hands together briskly until dry
    children under 6 years of age should be supervised when using this product

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • OTHER SAFETY INFORMATION

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

  • DOSAGE & ADMINISTRATION

    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.

  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a physician if skin irritation or rash develops.

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    3785 mL NDC: 79097-020-28 1 Gallon Label

  • INGREDIENTS AND APPEARANCE
    AFFEX CARE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79097-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79097-023-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    2NDC:79097-023-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    3NDC:79097-023-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    4NDC:79097-023-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    5NDC:79097-023-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    6NDC:79097-023-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    7NDC:79097-023-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    8NDC:79097-023-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
    9NDC:79097-023-751000000 mL in 1 TANK; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/13/2020
    Labeler - Autotrol Corporation (001755131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autotrol Corporation001755131label(79097-023) , manufacture(79097-023) , pack(79097-023)
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