Label: 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 March 30, 2022

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  • Active Ingredient(s)

    Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.
    Flammable keep away from fre or flame.

  • Do not use

    Do not use near eyes,in case of contact flush eyes with water

  • WHEN USING

    Do not use near eyes,in case of contact flush eyes with water

  • STOP USE

    Redness or irritationdevelops
    Persists for morehan 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Place a palmful (5 grams)of product in one hand. spread on both hands and rub into skin until dry (1-2 min)
    Children must be supervised in the use of this products.

  • Other information

    Store below105F°
    May discolor fabrics

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, carbomer, Triethanolamine

  • Package Label - Principal Display Panel

    29

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79867-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79867-001-0129 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 - Guangzhou meizi biotechnology co. LTD (403308233)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou meizi biotechnology co. LTD403308233manufacture(79867-001)