Label: INSTANT HAND SANITIZER 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 August 19, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Alcohol 67.0%

  • Purpose

    Antimicrobial

  • Use

    Use for hand-washing to decrease bacteria on the skin, only when wafer is not available.

  • Warnings

    Warnings Flammable, keep away from fire and flame. For external use only.

  • Do not use

    /

  • WHEN USING

    When using this product Do not get into eyes.
    If contact occurs, rinse eyes thoroughly witti water. May discolor some fabrics.

  • STOP USE

    Stop use and ask a doctor if Irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions wet hands thoroughly with product and allow to dry without wiping

  • Other information

    Other information store below 1os °F

  • Inactive ingredients

    AQUA, GLYCERIN, CARBOMER, TRIETHANOLAMINE

  • Package Label - Principal Display Panel

    79744-001-01 3780mL

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    instant hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79744-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79744-001-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Hangzhou KEON Biotech Co., Ltd. (413828663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou KEON Biotech Co., Ltd.413828663manufacture(79744-001)