Label: HAND SANITIZER- ethyl 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 May 25, 2020

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Use

    Decreases bacteria on hands

  • WARNINGS

    For external use only

    Do not use ■on broken skin & around eyes

    When using this product

    ■Keep away from fire or flame

    ■Using other topical acne drugs at the same time or right

    after use of this product may increase dryness or irritation of

    the skin . Only one drug should be used unless directed by a

    doctor.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children .If swallowed ,get medical

    help or contact a Poison on Control Center immediately

  • Directions

    Squeeze onto hands and rub hands and rub hands

    together briskly until dry

  • Inactive ingredients

    Deionized Water, Carbomer, Triethanolamine,Aloe

    barbadensis Gel,Fragrance ,Glycerin, Propylene Glycol,

    Vitamin E

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76897-001
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76897-001-0110 in 1 CARTON05/20/2020
    150 in 1 BOX
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:76897-001-0210 in 1 CARTON05/20/2020
    250 in 1 BOX
    212 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:76897-001-034 in 1 CARTON05/20/2020
    350 in 1 BOX
    315 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:76897-001-042 in 1 CARTON05/20/2020
    4125 in 1 BOX
    420 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:76897-001-052 in 1 CARTON05/20/2020
    5100 in 1 BOX
    530 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:76897-001-062 in 1 CARTON05/20/2020
    6100 in 1 BOX
    650 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:76897-001-072 in 1 CARTON05/20/2020
    7100 in 1 BOX
    760 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:76897-001-082 in 1 CARTON05/20/2020
    850 in 1 BOX
    8100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:76897-001-092 in 1 CARTON05/20/2020
    925 in 1 BOX
    9236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:76897-001-1024 in 1 CARTON05/20/2020
    10500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2020
    Labeler - NingBo Laiao Daily Chemical Co, Ltd. (554532225)
    Establishment
    NameAddressID/FEIBusiness Operations
    NingBo Laiao Daily Chemical Co, Ltd.554532225manufacture(76897-001)