Label: MADA 70% ALCOHOL- alcohol gel

  • NDC Code(s): 11928-005-55
  • 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 January 11, 2018

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  • ACTIVE INGREDIENT

    Active ingredient

    Alcohol Denat. 72% v/v

  • PURPOSE

    Purpose

    Antibacterial Agent

  • INDICATIONS & USAGE

    Uses

    Hand sanitizer to help reduce bacteria on the skin that could cause disease.

  • WARNINGS

    Warnings

    For external use only.

    FLAMMABLE Keep away from heat or flame.

    Avoid contact with eyes.

    If eye contact occurs, flush with water.

    Stop use if, in rare instances, redness or irritation develop.

    If condition persists for more than 72 hours, consult a physician.

    Keep out of reach of children.

    If swallowed, contact a physician or poison control center.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a small amount to palm.

    Briefly rub, covering hands with product until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine

  • PRINCIPAL DISPLAY PANEL

    PRODUCT CODE

    705555

    STORE BETWEEN

    33 TO 110F

    MADA GEL 70% ALCOHOL

    QUANTITY AND SIZE

    55 Gallon Drum

    BATCH NUMBER

    EXP:

    MANUFACTURED FOR:

    MADA MEDICAL

    625 WASHINGTON AVE.

    CARLSTADT. NJ 07072

    MADE IN USA

    Rev:01/18

    container label

  • INGREDIENTS AND APPEARANCE
    MADA 70% ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11928-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 L  in 100 L
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11928-005-55208 L in 1 DRUM; Type 0: Not a Combination Product10/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/12/2017
    Labeler - Mada Medical Products, Inc. (048411862)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(11928-005)
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