PURE AND CLEAN ANTI-BACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [MORGAN GALLACHER INC. DBA CUSTOM CHEMICAL FORMULATORS INC.]

PURE AND CLEAN ANTI-BACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [MORGAN GALLACHER INC. DBA CUSTOM CHEMICAL FORMULATORS INC.]
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NDC 50241-995-01, 50241-995-02
Set ID 249d63fc-ed59-4385-9967-82279d056566
Category HUMAN OTC DRUG LABEL
Packager Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Benzalkonium Chloride..........0.13%

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only.

  • When Using this Product

    Avoid contact with eyes.

    If contact occurs, rinse eyes thoroughly with water.

    Do not ingest. Stop use and contact a doctor if irritation and

    redness develop and conditions persist.

  • Keep out of reach of children.

    If swallowed, get medical help

    or contact Poison Control Center immediately.  

  • Directions

    Apply to wet hands.

    Work into a lather and rinse thoroughly.

    Children under 6 years of age should be supervised when using this product.

  • INERT INGREDIENTS:

    Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

  • Pure and Clean Antibacterial Hand Soap

    Pure and Clean Antibacterial Hand Soapimage descriptionimage description
    Fresh Fragrance Pure and Clean

  • INGREDIENTS AND APPEARANCE
    PURE AND CLEAN ANTI-BACTERIAL HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50241-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50241-995-051 in 1 BOX04/15/2018
    1NDC:50241-995-043.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50241-995-064 in 1 BOX04/15/2018
    2NDC:50241-995-043.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/15/201812/31/2021
    Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.028311595manufacture(50241-995) , api manufacture(50241-995) , pack(50241-995)

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