5406 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]

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5406 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]
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NDC 76138-116-03
Set ID 8d83b133-1240-4ec8-9fca-e4cbb84f6caf
Category HUMAN OTC DRUG LABEL
Packager Innovation Specialties
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient: Ethyl alcohol 62%.

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin. 

  • WARNINGS

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

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

  • 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.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

  • INACTIVE INGREDIENT

    Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

  • QUESTIONS

    Questions? HOTLINE # 1-855-755 5346 NPN# 80062390

  • STORAGE AND HANDLING

    Store at room temperature 15° to 30°C (59° to 86°F).

  • SPL UNCLASSIFIED SECTION

    Made in China For Innovation Line Los Angeles,
    CA 90066 Product # 5406

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    5406 HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-116
    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
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-116-0330 mL in 1 CONTAINER; Type 0: Not a Combination Product07/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2018
    Labeler - Innovation Specialties (030837314)
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