Label: MADA- alcohol gel

  • NDC Code(s): 11928-004-04
  • Packager: Mada Medical Products, Inc.
  • 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 November 1, 2017

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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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