Label: PROTZ ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • 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 May 18, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl alcohol 70% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use: Hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame. For external use only.

    Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

    Keep out of reach of children. Children under 6yrs old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

  • DOSAGE & ADMINISTRATION

    Directions: Apply the Gel on the hands and rub gently for 20 seconds until the product evaporates.

  • STORAGE AND HANDLING

    Other information: Store below 110°F (43°C). May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Glycerin, Aminomethylpropanol, Carbomer, Propylene Glycol.

  • SPL UNCLASSIFIED SECTION

    real protection

    ELIMINATES 99% OF GERMS AND BACTERIA

    EcoPure®

    Enhanced Bottle

     ✓ MOISTURIZING

       ✓ WITHOUT RINSING

    ✓ FAMILY USE

    Protz alcohol gel is a natural antiseptic and disinfectant that kills common germs without water or a hand towel. Its immediate action provides a special decontaminating action on the skin and dirty surfaces.

    Distributed by:

    Safety-Med Products, Inc. Burlington, WI 53105.

    www.safety-med.com

    Phone N   umber: 222 95 22 453

    MADE IN MEXICO BY MYM HIDROMINERALES S. DE R.L. DE C.V.

    Address: AV. 5 DE MAYO 600 C, CHIPILO, PUEBLA, C.P. 74325

    Batch and expiration on the packaging

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    PROTZ ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77872-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77872-600-40400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2020
    Labeler - MYM Hidrominerales, S, de R.L. de C.V. (951577510)
    Establishment
    NameAddressID/FEIBusiness Operations
    MYM Hidrominerales, S, de R.L. de C.V.951577510manufacture(77872-600)
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