Label: PFP POLYCLEAN HAND SANITIZER - GEL 72- gel hand sanitizer 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 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient [s]
    Ethyl Alcohol 72% 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 Ammonium Polyacryloyldimethyl Taurate*, Fragrance, Glycerin, Hydrogen peroxide, Isopropyl

    Alcohol, Sterile water, Ticacel*

    *May or May Not Contain

  • Product Labeling

    PfP INDUSTRIES                                   LOT Number :

    POLYClean Hand Sanitizer—GEL 72                                MADE IN TEXAS

    FLAMMABLE LIQUID

                3

    DOT: UN1170, II/III, Flammable Liquid,
    n.o.s (contains ethanol) Percent Active
    Ethyl Alcohol : 72% (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

    004 Gel 72

    res 8.22.20

  • INGREDIENTS AND APPEARANCE
    PFP POLYCLEAN HAND SANITIZER - GEL 72 
    gel hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77034-004
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containAMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    May containMETHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77034-004-011217 L in 1 TANK; 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!