Label: 4049 FIRST AID KIT- 4049 first aid kit

  • NDC Code(s): 0498-0501-34, 0498-0730-01, 0498-4049-01
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 29, 2018

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  • Neomycin Active ingredient (each gram contains)

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

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  • Neomycin Purpose

    First aid antibiotic

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  • Neomycin Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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  • Neomycin Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • 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 reach of children

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

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  • Neomycin 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
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  • Neomycin Other information

    • store at 15 o to 25 oC (59 o to 77 oF)
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  • Neomycin Inactive ingredient

    petrolatum

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  • Neomycin Questions?

    1-800-430-5490

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  • BZK Active ingredient

    Benzalkonium chloride 0.13%

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  • BZK Purpose

    First aid antiseptic

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  • BZK Uses

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

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  • BZK Warnings

    For external use only

    BZK
    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

    Stop use and ask a doctor if

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

    Keep out of reach of children

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

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  • BZK Directions

    tear open packet and use as a washcloth

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  • BZK Other information

    • store at room temperature 15 o to 30 oC (59 o to 86 oF)
    • do not reuse towelette
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  • BZK Inactive ingredient

    water

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  • BZK Questions

    1-800-430-5490

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  • Burn Cream Active ingredient

    Benzalkonium chloride 0.13%

    Lidocaine HCl 0.5%

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  • Burn Cream Purpose

    First aid antiseptic

    External analgesic

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  • Burn Cream Uses

    • prevent skin infection
    • for tempoorary relief of pain associated with minor burns
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  • Burn Cream Warnings

    For external use only

    Burn Cream
    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

    Burn Cream
    Ask a doctor beforef use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Burn Cream
    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Burn Cream
    Keep out of reach of children

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

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  • 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 the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor
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  • Burn Cream Other information

    • tamper evident sealed packets
    • do not use if packet is opened or torn
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  • 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

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  • Burn Cream Questions or comments?

    1-800-430-5490

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  • Neomycin Principal Display Panel
  • BZK Principal Display Panel
  • Burn Cream Principal Display Panel
  • 4049 Kit Label 010101-4354L
  • INGREDIENTS AND APPEARANCE
    4049 FIRST AID KIT 
    4049 first aid kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-4049
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-4049-01 1 in 1 KIT 11/29/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 5 PACKET 4.5 g
    Part 2 5 PACKET 4.5 g
    Part 3 10 PACKET 14 mL
    Part 1 of 3
    NEOMYCIN 
    antibiotic ointment
    Product Information
    Item Code (Source) NDC:0498-0730
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0730-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 03/31/2010
    Part 2 of 3
    FIRST AID BURN 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source) NDC:0498-0903
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 0.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/20/2017
    Part 3 of 3
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:0498-0501
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0501-34 10 in 1 BOX, UNIT-DOSE
    1 1.4 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 12/21/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/29/2018
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, inc 079287321 pack(0498-0730, 0498-4049)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0730, 0498-0903)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Maokang Medical 421317073 manufacture(0498-0501)
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