4049 First Aid Kit (Neomycin, BZK, Burn Cr 010101-4354L)

Drug Labeling and Warnings

Drug Details [pdf]

4049 FIRST AID KIT- 4049 first aid kit 
Honeywell Safety Products USA, Inc

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.

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4049 First Aid Kit (Neomycin, BZK, Burn Cr 010101-4354L)

Neomycin
Active ingredient (each gram contains)

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

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

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

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

Neomycin
Other information

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

Neomycin
Inactive ingredient

petrolatum

Neomycin
Questions?

1-800-430-5490

BZK
Active ingredient

Benzalkonium chloride 0.13%

BZK
Purpose

First aid antiseptic

BZK
Uses

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

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

BZK
Directions

tear open packet and use as a washcloth

BZK
Other information

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

BZK
Inactive ingredient

water

BZK
Questions

1-800-430-5490

Burn Cream
Active ingredient

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

Burn Cream
Purpose

First aid antiseptic

External analgesic

Burn Cream
Uses

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

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

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

Burn Cream
Other information

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

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

Burn Cream
Questions or comments?

1-800-430-5490

Neomycin
Principal Display Panel

Neomycin

BZK
Principal Display Panel

Antiseptic Wipe

Burn Cream
Principal Display Panel

Burn Cream

4049 Kit Label
010101-4354L

4049 Kit Label

4049 FIRST AID KIT 
4049 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4049
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4049-011 in 1 KIT11/29/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 15 PACKET 4.5 g
Part 210 PACKET 14 mL
Part 35 PACKET 4.5 g
Part 1 of 3
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC: 0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/31/2010
Part 2 of 3
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: 0498-0501-3410 in 1 BOX, UNIT-DOSE
11.4 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 finalpart333E12/21/2017
Part 3 of 3
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
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/29/201810/18/2019
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, inc079287321pack(0498-0730, 0498-4049)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0730, 0498-0903)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0501)

Revised: 10/2019