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 May 6, 2020

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  • Active ingredient

    Alcohol 62%

    Purpose

    Antiseptic

  • Use

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

  • Warnings

    For etemal use only
    Flammabl, keep away from fife and fames
    When using this poduct
    ■do not get intoeyes.
    iicnacocur, inine eyes hrougwth water
    Stop use and aska doctorif
    iritation and redness develop

    Keep out of reach of children

    Keep out of reach of cilden. if sallowed, get
    medical help or contact a Poison ControlCenter
    right away

  • Directions

    ■wethands trougly with poduotd and alw
    todry wthout wiping

  • INACTIVE INGREDIENT

    Water, PEG-40
    Hydrogenated Castor 0il, Fragrance,
    AcylatesC10-30 Alkyl Acrylate Crospolymer,
    Sodium Hydroxide, Denatonium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70939-003
    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
    WATER (UNII: 059QF0KO0R)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70939-003-02300 in 1 BOX05/07/2020
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70939-003-0148 in 1 BOX05/07/2020
    2250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70939-003-03200 in 1 BOX05/07/2020
    330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:70939-003-04200 in 1 BOX05/07/2020
    440 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:70939-003-05200 in 1 BOX05/07/2020
    550 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:70939-003-06200 in 1 BOX05/07/2020
    660 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:70939-003-07150 in 1 BOX05/07/2020
    7100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:70939-003-08150 in 1 BOX05/07/2020
    8120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:70939-003-0924 in 1 BOX05/07/2020
    9500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:70939-003-1012 in 1 BOX05/07/2020
    101000 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 finalpart333E05/06/2020
    Labeler - Dongguang Shuoguo Silicone Products Co., Ltd. (544426629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongguang Shuoguo Silicone Products Co., Ltd.544426629manufacture(70939-003)
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