Label: BITTOL ANTI-BACTERIAL HYGIENIC HAND CLEANING LIQUID- benzalkonium chloride liquid

  • NDC Code(s): 78564-003-01, 78564-003-02
  • Packager: Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
  • 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 September 16, 2020

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Uses

    • To decrease bacteria on the skin.
    • When water, soap & towel are not available.
    • Recommended for repeated use
  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame

    When using this product:

    Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if:

    Irritation and redness develops and last more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

  • Directions:

    Remove all your jewelry before use. Be careful to there is no visible dirtiness on the hands and make should that hands and skin not wet. Take 3-5 ml of Bittol Antibacterial Hygienic Hand Cleaning Liquid. Rub hands until it is dry properly.

  • Other Information

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients:

    Aqus/Water, Isopropyl Alcohol, Glycerin.

  • Package Labeling:1000ml

    Box

  • Package Labeling:750ml

    Box2

  • INGREDIENTS AND APPEARANCE
    BITTOL ANTI-BACTERIAL HYGIENIC HAND CLEANING LIQUID 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78564-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78564-003-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/2020
    2NDC:78564-003-02750 mL in 1 BOTTLE; Type 0: Not a Combination Product09/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/20/2020
    Labeler - Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi (565657236)
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