Label: PFP POLYCLEAN HAND SANITIZER - GEL 70- 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 August 3, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient [s]
    Ethyl Alcohol 70% v/v

  • 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 Isopropyl alcohol, Sterile Water, Hydrogen Peroxide, Ticacel,* Ammonium Polyacryloyldimethyl Taurate*

    *May or May not contain

  • Product Labeling

    PfP INDUSTRIES                                   LOT Number :

    POLYClean Hand Sanitizer—GEL 70                                 MADE IN TEXAS

    FLAMMABLE LIQUID

                3

    DOT: UN1170, II/III, Flammable Liquid,
    n.o.s (contains ethanol) Percent Active
    Ethyl Alcohol : 70% (v/v)

    Before handling this material, read ac-
    companied Safety Data Sheet for more
    detailed safety, health and environmen-
    tal data.

    Net Vol : 325 gal

    Address : PFP Industries LLC
    34011 Sunset lane Brookshire TX 77423
    Ph: 281 371 2000

    GEL 70 325Gal

    res

  • INGREDIENTS AND APPEARANCE
    PFP POLYCLEAN HAND SANITIZER - GEL 70 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77034-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containMETHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    May containAMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77034-002-011217 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/23/2020
    Labeler - Pfp Industries, LLC (a Global Enterprise) (080458439)
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