Label: 3-STEP FIRST AID KIT- povidone-iodine, lidocaine hydrochloride, benzalkonium chloride kit

  • Category: HUMAN OTC DRUG LABEL

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 March 18, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug FactsActive Ingredients

    Antiseptic Swabs

    Lidocaine Hydrochloride 1.0%

    Benzalkonium Chloride 0.11%

    Povidone Iodine swabs:

    Povidone Iodine 10%, equal to available Iodine 1% for antiseptic

  • Purpose

    Lidocaine Hydrochloride for Pain Relief

    Benzalkonium Chloride for Antiseptic

    Povidone Iodine for Antiseptis

  • Uses

    First aid to help prevent infection, and temporarily reliever pain and itching associated with minor cuts. scrapes and burn

  • Keep out of reach of children

    Keeo out of reach of children

  • Directions

    • Do not use if label seal is broken prior to purchase.
    • Hold the swab vertically, with the color ring band tip upwards. Hold in the center of the stem with one hand and at the color band with the other.
    • Bend the tip at the color band to one side until it snaps.
    • Apply the product to the affected area.
    • Discard swab after use.
  • Warnings

    For external use only. Keep out of eyes. Non-Sterile. Discontinue use if irritation occurs. Do not insert inear canal. Keep at room temperture. Avoid direct sunlight.

    Do not use. Swabs if you are sensitive to any product ingredients. in the eyes. longer than one week unless directed by a doctor.

    Stop use and ask a doctor if you have deep or punchture wounds, or serious burns. redness, irritation, sweeling or pain continues or increases, infection occurs

  • Other information

    For adult and children 2 and older: Clean affected area. Apply 1 to 3 times daily. May be covered with a bandage.

    Children under 2 years of age: Consult a doctor.

    Avoid storing at excessive heat.

  • Inactive Ingredients

    Antiseptic swab: Dizolidinyl Urea, Methylparaben, Propylparaben, Water

    Providone Iodine Swab: Glcerin, Water

  • Manufacturer Statement

    Soft cotton tip swabs individually filled with Antiseptic or Iodine. Ready to use and convenient to carry for fast, clean, safe first aid.

    Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA

    The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

  • Package and label

    Image of first aid carton label

    Image of first aid carton label

  • INGREDIENTS AND APPEARANCE
    3-STEP FIRST AID KIT 
    povidone-iodine, lidocaine hydrochloride, benzalkonium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-000-231 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 2 mL
    Part 21 PACKET 2 mL
    Part 1 of 2
    ANTISEPTIC AND ANESTHETIC SWAB 
    lidocaine hydrochloride, benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:65734-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS100 mg  in 10 mL
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride11 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-125-012 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/01/2003
    Part 2 of 2
    POVIDONE-IODINE SWAB 
    povidone-iodine liquid
    Product Information
    Item Code (Source)NDC:65734-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine100 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-119-012 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549repack(65734-000) , manufacture(65734-125, 65734-119)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!