Label: CLEAN CONCEPT LAVENDER CALM ANTIBACTERIAL FOAMING HAND- benzalkonium chloride 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 November 25, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT(S)

    Benzalkonium Chloride 0.12%

    PURPOSE

    Antibacterial Hand Cleaner

  • USE(S)

    For hand washing to decrease bacteria on the skin

  • WARNINGS

    For external use only

    Do Not Use

    • In eyes or mouth

    When using this product

    • Keep out of eyes and mouth. If contact with eyes, rinse eyes promptly and thoroughly with water
    • Discontinue if redness or irritation develops

    Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

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

  • DIRECTIONS

    • Wet hands and desired area
    • Apply product to adequately cover the surface
    • Scrub thoroughly for atleast 30 seconds
    • Rinse

  • OTHER INFORMATION

    • Store between (15-20C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENTS

    Water (Aqua), glycerin, cocamidopropyl hydroxysultaine and cocamide, cocamidpropyl PGDimonium chloride phosphate, fragrance, benzl alcohol, citric acid

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    CLEAN CONCEPT LAVENDER CALM ANTIBACTERIAL FOAMING HAND 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74830-544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    COCAMIDE (UNII: 3YXD33R71G)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74830-544-01547 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/31/2020
    Labeler - Economy Polymers and Chemicals (008087603)
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