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 21, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria ont he skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For External Use Only

    When using this product

    avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if skin irritation or rash develops and continues for more than 72 hours.

    Keep out of reach of children.

    If swallowed get medical help or contact your Poison Control right away.

  • Directions

    • Place a palmful (5 grams) of product in one hand. 
    • Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).
  • Other information

    • Do not store above 105°F, 
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics.
  • Inactive ingredients

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

  • Package Labeling: 15 ml

    Label

  • Package Labeling: 53 ml

    Label2

  • Package Labeling: 60 ml

    Label3

  • Package Labeling: 473 ml

    Label4

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-194
    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 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:74341-194-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    2NDC:74341-194-5353 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202012/31/2021
    3NDC:74341-194-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    4NDC:74341-194-73473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/202012/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/20/2020
    Labeler - Newacme llc (117465743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co.,Ltd.544377996manufacture(74341-194)
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