Label: MODEL AA-2012 kit

  • NDC Code(s): 27860-014-01, 67777-245-01, 68356-126-02
  • Packager: AEROSPACE ACCESSORY SERVICE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated October 2, 2023

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  • Antiseptic Wipes Active ingredient

    Benzalkonium Chloride 0.13% v/v

  • Antiseptic Wipes Purpose

    First Aid Antiseptic

  • Antiseptic Wipes Uses

    First Aid Antiseptic

  • Antiseptic Wipes Warnings

    For external use only

    Do not use

    Do not use it in the eyes or apply 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 the condition persists or gets worse. Do not use it for longer than 1 week unless directed by a doctor.

    Antiseptic Wipes

    Keep out of reach of children

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

  • Antiseptic Wipes Directions

    Tear open pouch and use as part of your daily cleansing routine.

    Clean the affected area.

    Apply this product on the area 1 to 3 times daily.

    May be covered with a sterile bandage.

    If bandaged, let dry first.

  • Antiseptic Wipes Other information

    • store at room temperature between 59-86 F
    • If contact with eyes occurs, flush eyes with water
  • Antiseptic Wipes Inactive ingredients

    Purified water

  • Antiseptic Wipes Questions

    Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

  • BZK Pads Active ingredient

    Benzalkonium Chloride 0.13% v/v

  • BZK Pads Purpose

    First Aid Antiseptic

  • BZK Pads Uses

    First aid to help prevent skin infection in minor cuts, scrapes and burns

  • BZK Pads Warnings

    For external use only

    Do not use

    • As an antiseptic for more than 1 week
    • In the eyes

    Ask a Doctor before use if you have

    deep puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • irritation or redness develop
    • Condition persistor gets worse

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center ( 1-800-222-1222) right away

  • BZK Pads Directions

    • Clean the affected area
    • May be covered with a sterile bandage
    • If bandaged, let dry first
  • BZK Pads Other Information

    • Store at room temperature 15-30C (59-86F)
    • Avoid excessive heat
    • Temper evident. Do not use if packet is torn or cut
  • BZK Pads Inactive ingredients

    Water, may contain Methylchloroisothiazolinone/Methlylisothiazolinone

  • BZK Pads Questions

    1-800-DYNAREX Monday-Friday 9AM-5PM EST

  • Antiseptic Wipes Principal Display Panel

    label

  • BZK Pads Principal Display Panel

    label

  • Model AA-2012

    label

  • INGREDIENTS AND APPEARANCE
    MODEL AA-2012 
    model aa-2012 kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27860-014
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27860-014-011 in 1 KIT06/01/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 PACKET 0.13 g  in 100 
    Part 22 PACKET 1.3 mL
    Part 1 of 2
    LORIS BZK  ANTISEPTIC WIPES
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:68356-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68356-126-022.6 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/21/2012
    Part 2 of 2
    BZK PADS 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:67777-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-245-01100 in 1 BOX
    10.55 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2022
    Labeler - AEROSPACE ACCESSORY SERVICE (859100547)
    Registrant - AEROSPACE ACCESSORY SERVICE (859100547)
    Establishment
    NameAddressID/FEIBusiness Operations
    LernaPharm Loris Inc206940905manufacture(27860-014)
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