Label: ANTIBACTERIAL- benzalkonium chloride 0.13% liquid

  • 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 17, 2020

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  • Active ingredients

    Benzalkonium chloride 0.13%.................Anitbacterial Hand soap

  • Purpose

    Antibacterial Hand Soap

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

  • When using this product

    • avoid contact with eyes.  If contact occurs, rinse eyes with water
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Squeeze onto wet hands or body sponge 
    • Work into lather 
    • Wash skin,rinse and dry toroughly
  • INACTIVE INGREDIENT

    water, sodium laureth sulfate , cocamidopropyl betaine, sodium chloride, glycerin,

    fragrance, polyquatemium-10 , PEG-8 , ciTric acid, tetrasodium EDTA, cocamidopropyl pg-dimonium chrolide,

    methylchloroisothiazolinone , methlisothiazolinone, Orange (CI 15985).

  • Adverse Reactions

    TSM BRANDS LLC

    540 Equinox Ln Manlapan, NJ 07726

    Made in TURKEY.

  • principal display panel

    bath

    BATHCLEAN

    b2b1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76772-010-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    2NDC:76772-010-68680 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    3NDC:76772-010-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    4NDC:76772-010-33333 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Establishment
    NameAddressID/FEIBusiness Operations
    TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-010)
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