Label: BZK ANTISEPTIC SWAB- benzalkonium chloride swab

  • NDC Code(s): 54429-0103-1, 54429-0103-2
  • Packager: Foshan Flying Medical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/14

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    ACTIVE INGREDIENT

    Benzalkonium chloride .13% w/v

    PURPOSE

    Antiseptic

    USE

    Antiseptic cleaning of face, hands and body without soap and water.

    WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    DO NOT USE, in the eyes or apply over large areas of the body.

    STOP USE: If irritation, redness or other symptoms develop.

    ASK A DOCTOR: If condition persists or gets worse.

    CAUTION: Keep out of reach of children

    If swallowed, get medical help or contact aPoisonControlCenterright away.

    DIRECTIONS

    Tear open packet, unfold and use as a washcloth.

    OTHER INFORMATION

    Store at room temperature.

    INACTIVE INGREDIENTS

    Purified water.

    image of labeling

    Close
  • INACTIVE INGREDIENTS

    Purified water

    Close
  • DIRECTIONS

    Tear open packet, unfold and use as a washcloth.

    Close
  • WARNINGS

    For external use only. Flammable, keep away from fire or flame.

    DO NOT USE, in the eyes or apply over large areas of the body.

    STOP USE: If irritation, redness or other symptoms develop.

    ASK A DOCTOR: If condition persists or gets worse.

    Close
  • USE

    Antiseptic cleaning of face, hands and body without soap and water.

    Close
  • CAUTION: Keep out of reach of children

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

    Close
  • PURPOSE

    Antiseptic

    Close
  • ACTIVE INGREDIENT

    Benzalkonium chloride .13% w/v

    image description

    Close
  • INGREDIENTS AND APPEARANCE
    BZK ANTISEPTIC SWAB 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54429-0103
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54429-0103-1 1.4 mL in 1 PACKET
    2 NDC:54429-0103-2 1.4 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/27/2012
    Labeler - Foshan Flying Medical Products Co., Ltd. (527021584)
    Registrant - Foshan Flying Medical Products Co., Ltd. (527021584)
    Establishment
    Name Address ID/FEI Business Operations
    Foshan Flying Medical Products Co., Ltd. 527021584 manufacture(54429-0103)
    Close