MADA (ALCOHOL) GEL [MADA MEDICAL PRODUCTS, INC.]

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MADA (ALCOHOL) GEL [MADA MEDICAL PRODUCTS, INC.]
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NDC 11928-004-04
Set ID b6d9d394-f660-490c-b3b3-d9e04f368115
Category HUMAN OTC DRUG LABEL
Packager Mada Medical Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose

    Antibacterial Agent

  • INDICATIONS & USAGE

    Uses

    For hand cleaning to decrease bacteria on skin.

  • WARNINGS

    Warnings

    For external use only.

    FLAMMABLE Keep away from heat or flame.

    Do not use in eyes.

    In case of contact, rinse thoroughly.

    Stop use and ask a doctor if irritation and redness appears and lasts.

    Keep out of reach of children.

    If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    Directions

    To decrease bacteria on skin, apply a small amount to palm.

    Briskly rub,covering hands with product until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol

  • PRINCIPAL DISPLAY PANEL

    MadaGel

    Instant

    Hand Sanitizer

    with

    Moisturizers

    Broad Spectrum

    Antimicrobial Effectiveness

    Kills 99.9% of

    common bacteria

    in seconds without

    using water.

    4 Fl. Oz. (118ml)

    container label

  • INGREDIENTS AND APPEARANCE
    MADA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11928-004
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11928-004-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2004
    Labeler - Mada Medical Products, Inc. (048411862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(11928-004)
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