Label: AEROCLEANSE HAND SANITIZER- hand sanitizer 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 March 31, 2022

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  • Active Ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

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

    Stop use and ask a doctor if irritation 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

    • 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.
  • Inactive Ingredients

    Water, Acrylates Copolymer, Trimethylene Glycol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Triethanolamine

  • Other Information

    • Store below 104°F (40°C)
    • May discolor certain fabrics or surfaces
  • Product Label

    ACG120_4ozACG240_8ozACG500_16ozACG1000_1LACG3785 1 Gal

  • INGREDIENTS AND APPEARANCE
    AEROCLEANSE HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-131
    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
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-131-01237 mL in 1 PACKAGE; Type 0: Not a Combination Product04/26/2020
    2NDC:55305-131-023780 mL in 1 PACKAGE; Type 0: Not a Combination Product04/26/2020
    3NDC:55305-131-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    4NDC:55305-131-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    5NDC:55305-131-05474 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    6NDC:55305-131-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/26/2020
    Labeler - Aero Healthcare US LLC (008186174)
    Registrant - Aero Healthcare US LLC (008186174)
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