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 January 28, 2022

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses:

    For Hand Sanitizing

  • Warnings:

    For external use only-hands.

    Flammable.  Keep away from heat and flame

    When using this product

    • Keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.

    Stop use or ask a doctor

    if skin irritation develops.

    Keep out of reach of children.

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

  • Directions:

    • Wet hands thoroughly with a product and allow to dry without wiping
    • For children under 6 use only under adult Supervision.
    • Not recommended for infants.
  • Other information:

    Do not store above 105 oF.  May discolor some fabrics.  Harmful to wood finishes and plastics.

  • Inactive Ingredients:

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl ACetate, Triethanolamine, Water.

  • Package Labeling: 74341-191-08

    236mL

  • Package Labeling: 74341-191-16

    473mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74341-191-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:74341-191-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Newacme LLC (117465743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co.,Ltd.544377996manufacture(74341-191)
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