Label: LIGHTS SWABSTICK- benzalkonium chloride solution

  • NDC Code(s): 61333-208-01
  • Packager: Lights Medical Manufacture Co., Ltd.
  • 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 January 16, 2023

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  • Active ingredient

    benzalkonium chloride 0.133%

  • Purpose

    Antiseptic

  • Uses

    First aid to help reduce the risk of infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only.

    Do not use in the eyes or apply over over large areas of the body.

    In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

    Stop use and consult a doctor if condition persists or gets worse

    Do not use for more than 1 week unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Tear open packet and use as part of your daily cleansing routine

    Clean the affected area

    Apply this product on area 1 to 3 times daily

    Maybe covered by a sterile bandage

    If bandaged, let dry first

  • INACTIVE INGREDIENT

    Water

  • STORAGE AND HANDLING

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIGHTS SWABSTICK 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61333-208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.133 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61333-208-013 in 1 PACKAGE03/07/2022
    11.67 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/07/2022
    Labeler - Lights Medical Manufacture Co., Ltd. (529128649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(61333-208)
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