Label: HYDRATING ANTI-BACTERIAL HAND SANITIZER- alcohol lotion

  • NDC Code(s): 58411-535-10, 58411-535-11, 58411-535-12
  • Packager: SHISEIDO AMERICAS CORPORATION
  • 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 April 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    • Hand sanitizer to help reduce bacteria on skin
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics and surfaces
  • Inactive ingredients

    water, glycerin, carbomer, triethanolamine

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

    SHISEIDO
    AMERICAS

    Hydrating Anti-Bacterial
    Hand Sanitizer

    THE
    BEAUTY OF HELPING
    OTHERS

    SERVING OUR
    COMMUNITIES

    Label donated by
    Standwill Packaging

    3.4 FL. OZ. (100 mL)

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDRATING ANTI-BACTERIAL HAND SANITIZER 
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-535
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-535-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:58411-535-11150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    3NDC:58411-535-123785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/01/2020
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-535) , ANALYSIS(58411-535)
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