5257 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]

5257 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]
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NDC 76138-121-03
Set ID c62f5213-3450-44c2-982c-1969a443d7ee
Category HUMAN OTC DRUG LABEL
Packager Innovation Specialties
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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.

    When using this product Avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor If redness or irritation develop and persist for more than 72 hours.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Spread on both hands, rub in, let dry.

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions? Call 1-855-755-5346

  • SPL UNCLASSIFIED SECTION

    Made in China for Innovation Line Culver City, CA 90230

    NPN# 80062390

  • Packaging

    5257 Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    5257 HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-121
    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:76138-121-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2019
    Labeler - Innovation Specialties (030837314)

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