Label: 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 April 20, 2020

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  • Drug Facts

  • Active ingredient[s]

    Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use[s]:

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

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • On childern less then 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 ask a doctor

    If irritation or rash or 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

    • Put 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 40C (104F)
  • Inactive ingrediends

    Deionized water, Glycerin, Fragrance, Benzalkonium chloride, Hydroxyethyl cellulose

  • Package Labeling: 60ml

    Label

  • Package Labeling: 100ml

    Label2

  • Package Labeling: 250ml

    250ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75376-000
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75376-000-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    2NDC:75376-000-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    3NDC:75376-000-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2020
    Labeler - Guangzhou Danting Bath&Body Care Industry Co. Ltd. (545337886)
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