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 October 24, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 72% v/v

  • Purpose

     Antiseptic

  • Use

    Hand sanitizer to Helps reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • Warnings

    For external use only: hands.

    Flammable. Keep away from heat or flame.

    Do not use 

    On children under the age of 2 months. On any open wounds.

    When using this product

    Keep out of eyes, ears, and mouth. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness occurs. These may be signs of serious reaction.

    Other Information:

    Store between 50-86℉ (15-30℃) 。

    Avoid freezing and excessive heat above 104℉ (40℃).

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    Place a dime size amount into hand. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallwing.

  • Inactive ingredients

    Carbmer, Fragrance, Glycerin, Propylene Glycol, Triethanolamine, Disodium ETDA, Tocopheryl Acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75613-010-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/09/2020
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-010)
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