Label: CHEMSTATION HACCP Q E2- benzalkonium chloride liquid

  • NDC Code(s): 71212-101-00, 71212-101-01
  • Packager: ChemStation
  • 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 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.12% w/w

  • PURPOSE

    Purpose

    Antiseptic Hand Cleanser

  • INDICATIONS & USAGE

    Uses

    • handwash to help reduce bacteria that potentially can cause disease
    • helps to prevent cross contamination
    • helps prevent drying of skin
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product do not use in or near eyes.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands and wrists with clean, running water
    • apply appropriate amount of product
    • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
    • rinse thoroughly with running water
    • dry hands completely (incomplete drying may result in chapped skin)
  • STORAGE AND HANDLING

    Other Information

    store in a cool, dry place below 104° F (40° C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, cocamidopropyl betaine, C12-14 amine oxides, 1,2 propanediol, glycerol, guar gum, xantham gum, benzyl alcohol, dehydroacetic acid, tetra-sodium EDTA

  • QUESTIONS

    Questions?

    Contact ChemStation at 800-554-8265 Mon-Fri 9am-5pm EST

  • OTHER SAFETY INFORMATION

    Can cause eye irritation

    Response:

    IF IN EYES: Contact may cause mild, transient irritation. For irritation, rinse cautiously with water for several minutes.

    Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention.

    IF ON SKIN (or hair): Not expected to be irritating, sensitizing, photoallerginic or phototoxic when used as intended. If irritation occurs following intended use or prolonged contact, it is expected to be mild and transient.

    Storage: Store in a dry area at normal temperatures.

    Disposal: Dispose of contents/container to an approved waste disposal plant.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    ChemStation Buyers Association, Inc.

    3400 Encrete Lane

    Dayton, OH 45439

    www.chemstation.com

  • PRINCIPAL DISPLAY PANEL

    CHEMSTATION®

    HACCP Q E2 Sanitizing Liquid Soap

    Benzalkonium Chloride

    Rich, thick lather

    Our System Is The Solution

    Net Contents: 55 U.S. Gallons (208.198 liters)

    CS10002 HACCP E2 55 Gal

  • INGREDIENTS AND APPEARANCE
    CHEMSTATION HACCP Q E2 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71212-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    (C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)  
    GUAR GUM (UNII: E89I1637KE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71212-101-00208.198 L in 1 DRUM; Type 0: Not a Combination Product03/08/2017
    2NDC:71212-101-014 in 1 BOX03/08/2017
    23.79 L in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/08/2017
    Labeler - ChemStation (177350279)
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