4280 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]

4280 FIRST AID KIT KIT [HONEYWELL SAFETY PRODUCTS USA, INC]
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NDC 0498-0121-00, 0498-0501-00, 0498-0750-35, 0498-4280-01
Set ID 86c490c0-9579-5d01-e053-2a91aa0a816f
Category HUMAN OTC DRUG LABEL
Packager Honeywell Safety Products USA, INC
Generic Name
Product Class Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number
  • First Aid Burn Cream Active ingredient

    Benzalkonium chloride o.13%

    Lidocaine HCl 0.5%

  • First Aid Burn Cream Purpose

    First aid antiseptic

    External analgesic

  • First Aid Burn Cream Uses

    • prevent skin infection
    • for temporary relief of pain associated with minor burns
  • First Aid Burn Cream Warnings

    For external use only

    Do not use

    • in or near the eyes
    • if you are allergic to any of the ingredients
    • in large areas of the body, particularly over raw surfaces or blistered areas
    • for more than 10 days


    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • First Aid Burn Cream Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
  • First Aid Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
  • First Aid Burn Cream Inactive ingredients

    aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

  • First Aid Burn Cream Questions

    1-800-430-5490

  • Triple Active ingredient (each gram contains)

    Bacitracin zinc 400 units - Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base) Polymyxin B sulfate 5000 units

  • Triple Purpose

    First aid antibiotic
    First aid antibiotic
    First aid antibiotic

  • Triple Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Triple Warnings


    For external use only


    Allergy alert do not use if you are allergic to any of the ingredients

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • a deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
    • you need to use longer than 1 week

    Keep out of the reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Triple Directions

    • clean the affected area
    • apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Triple Other information

    store at 15 0 to 25 0 C (59 0 to 77 0 F) tamper evident sealed packets - do not use if packet is torn or opened

  • Triple Inactive ingredient

    petrolatum

  • Triple Questions

    1-800-430-5490

  • BZK Active ingredient

    Benzalkonium chloride 0.13% w/v

  • BZK Purpose

    First aid antiseptic

  • BZK Uses

    Antiseptic cleansing of face, hands, and body without soap and water

  • BZK Warnings


    For external use only

    Do not use

    • in the eyes or over large areas of the body
    • on mucous membranes
    • on irritated skin
    • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
    • longer than 1 week unless directed by a doctor

    Keep out of reach of children

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

    Stop use and ask a doctor if

    • irritation, redness or other symptoms develop
    • the condition persists or gets worse
  • BZK Directions

    • tear open packet and use as a washcloth
  • BZK Other information

    • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
    • do not reuse towelette
  • BZK Inactive ingredients

    water

  • BZK Questions

    1-800-430-5490

  • PVP Active ingredient

    Povidone-iodine 10%

    (equivalent to 1% titratable iodine)

  • PVP Purpose


    First aid antiseptic

  • PVP Uses

    • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • PVP Warnings

    For external use only.

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • irritation and redness develops

    Keep out of reach of children.

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

    • clean the affected area
    • apply1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
    • discard wipe after single use
  • PVP Other information

    • do not use on individuals who are allergic or sensitive to iodine
    • store at controlled temperature 59-86ºF (15-30ºC)
    • do not use if pouch is open or torn
  • PVP Inactive ingredients

    nonoxynol 9, water

  • PVP Questions

    1-800-430-5490

  • 4280 SF00002263 Kit Contents

    1 TRIPLE ANTIBIOTIC 10 PER

    1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

    1 GAUZE BANDAGE, 2" X 6 YD,2 PER

    2 EYEWASH BOTTLES 1 OZ, UNITIZED 2/BX

    1 BANDAGE COMP, 4" OFFSET, 1 PER

    1 PVP IODINE WIPES 10 PER

    1 ADH BDG, CLOTH, 1"X3", 16 PER

    1 FIRST AID GUIDE ASHI

    1 RESPONSE KIT BLOODBORNE PATHOG

    1 SCISSOR BDGE 4" RED PLS HDL

    LBL STOCK 6-3/8"X4"

    LBL STOCK 4"X2-7/8"

    1 LBL STOCK 3"x1-7/8"

    2 PR LRG NITRILE GLVES ZIP BAG

    1 KIT, PP 16 UNIT FA

    1 TRI BNDG NON WOVEN 40"X40"X56"

    1 COLD PACK UNIT 4"X6" BULK

    1 GZE PAD 3X3 10 2 UNIT

    1 FIRST AID CREAM 10

  • First Aid Burn Cream Principal Display Panel

    FABC label

  • Triple Principal Display Panel

    Triple Antibiotic

  • BZK Principal Display Panel

    Antiseptic Wipe

  • PVP Principal Display Panel

    PVP SwabPVP

  • 4280 Kit Label SF00002263

    4280 label

  • INGREDIENTS AND APPEARANCE
    4280 FIRST AID KIT 
    4280 first aid kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4280
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-4280-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 110 PACKET 9 g
    Part 21 PACKET 1.4 mL
    Part 310 PACKET 9 g
    Part 410 POUCH 3 mL
    Part 1 of 4
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:0498-0903
    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
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.9 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 finalpart333A12/20/2017
    Part 2 of 4
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source)NDC:0498-0501
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0501-001.4 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 finalpart333E09/18/2018
    Part 3 of 4
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Item Code (Source)NDC:0498-0750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/19/2018
    Part 4 of 4
    PVP IODINE WIPE 
    povidone-iodine 10% swab
    Product Information
    Item Code (Source)NDC:0498-0121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2018
    Labeler - Honeywell Safety Products USA, INC (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, INC079287321pack(0498-4280)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0498-0903, 0498-0750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical421317073manufacture(0498-0501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Medical Biotext532775194manufacture(0498-0121)

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