Label: PURE SOURCE HAND SANITIZER- alcohol gel

  • NDC Code(s): 65121-054-02, 65121-054-16
  • Packager: Pure Source, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Topical Antimicrobial

  • USES

    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

    • in 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.

  • 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40ºC (104ºF)
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf  (Aloe Vera Gel) Juice, Aminomethylpropanediol, Aqua (Deionized Water), Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polysorbate-20

  • QUESTIONS

    Questions? (866) 565-575

  • Package Labeling: 65121-054-02

    60mL

  • Package Labeling: 65121-054-16

    473mL

  • INGREDIENTS AND APPEARANCE
    PURE SOURCE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-054
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-054-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/202001/01/2023
    2NDC:65121-054-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/202001/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/01/202001/01/2023
    Labeler - Pure Source, LLC (080354456)
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