Label: PFP POLYCLEAN HAND SANITIZER - LIQ 80- ethyl alcohol liquid

  • 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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient [s]
    Ethyl Alcohol 80%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Use [s]
    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    Warnings
    For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    Do not use
    •In children less than 2 months of age
    •On open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    •Place enough product on hands to cover all surfaces. Rub hands together until dry.
    •Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER SAFETY INFORMATION

    Other Information
    •Store between 15-30C (59-86F)
    •Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients  glycerin, hydrogen peroxide, sterile water

  • Product Labeling

    PfP INDUSTRIES

    Hand Sanitizer—Liquid 80

    Alcohol Based

    Topical Solution

    Hand Sanitizer

    Non-Sterile Solution

    Net Weight: 325 gal

    Product of Texas

    PfP INDUSTRIES                                   LOT Number :

    POLYclean Hand Sanitizer—Liquid 80  Made in Texas

    FLAMMABLE LIQUID

                3

    DOT: UN1993, 3, II, Flammable Liquid,

    n.o.s (contains ethanol) Percent Active

    Alcohol : 80% (v/v)

    Before handling this material, read ac-

    companied Safety Data Sheet for more

    detailed safety, health and environmen-

    tal data.

    PFP Industries LLC

    34011 Sunset Lane

    Brookshire, TX 77423

    Ph: 346 777 5215

    Front

    PfpDFacts

    res

  • INGREDIENTS AND APPEARANCE
    PFP POLYCLEAN HAND SANITIZER - LIQ 80 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77034-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77034-001-011216 L in 1 CONTAINER; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/27/2020
    Labeler - Pfp Industries, LLC (a Global Enterprise) (080458439)
    Registrant - Pfp Industries, LLC (a Global Enterprise) (080458439)
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