Label: ANTISEPTIC HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Drug Facts

  • Active ingredient

    Alcohol 72%

    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 Poison Control Center right away.

  • 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.
  • Other information

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

    Water(Aqua), Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethyl Propanol, Isopropyl Myristate, Phenoxyethanol, Ethylhexylglycerin, Fragrance- Lavender.

  • Questions?

    866-961-6181

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78229-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.72 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYL GLYCOLATE (UNII: 3H5QAS0HZX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78229-005-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/28/2020
    Labeler - Beauty Partners LLC (080320170)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(78229-005)
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