Label: HOBBY ANTIBACTERIAL HANDWASH- benzalkonium chloride liquid

  • NDC Code(s): 73789-0442-1
  • Packager: Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim 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 October 23, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antibacterial

  • Use

    for washing hands to decrease bacteria on skin.

  • Warnings

    For external use only

    When using this product avoid contact with eyes, in case of eye contact, flush with water.

    Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children. If swallowed, get medical help or go to Poison Control Center right away.

  • Directions

    Pump onto wet hands, vigorously work into a lather and rinse thoroughly.

  • Other information

    Store in a cool dry place below 104 °F.

  • Inactive ingredients

    water, cocamidopropyl betaine, sodium laureth sulfate, cocamide DEA, lauryl glucoside, glycerin, fragrance, citric acid, benzophenone-4, propylene glycol, sodium chloride, benzyl alcohol, magnesium nitrate, methyIchloroisothiazolinone, methylisothiazolinone, red 33, blue 1

  • Principal Display Panel - 400 mL Label

    HOBBY®

    Antibacterial
    Liquid Hand Soap

    BERRY MEDLEY

    13.5 FL OZ
    (400 ml)

    Principal Display Panel - 400 mL Label
  • Principal Display Panel - 400 mL Label

    HOBBY®

    Antibacterial
    Liquid Hand Soap

    TROPICAL BEACH

    13.5 FL OZ
    (400 ml)

    Principal Display Panel - 400 mL Label
  • Principal Display Panel - 400 mL Label

    HOBBY®

    Antibacterial
    Liquid Hand Soap

    PEACH DREAM

    13.5 FL OZ
    (400 ml)

    Principal Display Panel - 400 mL Label
  • INGREDIENTS AND APPEARANCE
    HOBBY ANTIBACTERIAL HANDWASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73789-0442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Magnesium Citrate (UNII: RHO26O1T9V)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Benzyl Benzoate (UNII: N863NB338G)  
    Benzyl Salicylate (UNII: WAO5MNK9TU)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Magnesium Nitrate (UNII: 77CBG3UN78)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73789-0442-16 in 1 CASE10/23/2020
    1400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/23/2020
    Labeler - Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim Sirketi (552240889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hobi Kozmetik Imalat Sanayi Ve Ticaret Anonim Sirketi 533139227MANUFACTURE(73789-0442)
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