4218 FIRST AID KIT- 4218 first aid 
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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4218 First Aid Kit (neomycin, Ammonia Inh, EW, Burn Jel, PVP Wipes, Sting Relief) 010424-4224

Active ingredient

Ammonia 15%

Purpose

Respiratory stimulant

Uses

to prevent or treat fainting

Warnings

For external use only

Do not use

  • if you have asthma or emphysema

Stop use and ask a doctor if

  • condition persists

Keep out of reach of children

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

Directions

Other information

store at room temperature away from light

Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Questions or Comments

1-800-430-5490

Burn Jel
Active ingredient

Lidocaine HCl 2.0%

Burn Jel
Purpose

External analgesic

Burn Jel
Uses

Burn Jel
Warnings

For external use only

Do not use

  • on large areas of the body, particularly over raw surfaces or blistered areas

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • the condition gets worse
  • symptoms persist for more than 7 days
  • condition clears up and recurs within a few days

Keep out of reach of children

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

Burn JEl
Directions

Burn Jel
Other information

Burn Jel
Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel
Questions

1-800-430-5490

Sting Relief
Active ingredient (in each wipe)

Ethyl alcohol 50.0% Lidocaine HCl 2.0%

Sting Relief
Purpose

Antiseptic / Topical pain relief

Sting Relief
Uses

prevent infection in minor scrapes, and temporary relief of itching of insect bites

Sting Relief
Warnings


For external use only
Flammable, keep away from open fire or flame

Do not use

  • over large areas of the body
  • in eyes
  • over raw or blistered areas

Stop use and ask a doctor

  • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Sting Relief
Directions

Sting Relief
Inactive ingredient

benzalkonium chloride, menthol, and purified water

Sting Relief
Questions or Comments?

1-800-430-5490

PVP
Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

PVP
Purpose

First aid antisepti

PVP
Uses

PVP
Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

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


When using this product

  • do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

  • conditions persists or gets worse
  • irritation and redness develops

Keep out of reach of children

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

PVP
Directioons

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.

PVP
Other information

PVP
Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

PVP
Questions and Comments?

1-800-430-5490

Neomycin
Active ingredient

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

Neomycin
Purpose

First aid antiseptic

Neomycin
Uses

First aid antibioticfirst aid to help prevent infection in

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

Neomycin
Other information

Neomycin
Inactive ingredient

petrolatum

Neomycin
Questions?

1-800-430-5490

4218
010424-4224 Kit Contents

2 KNUCKLE BAND 8 PER

1 NEOMYCIN ANTIBIOTIC 10 PER

1 AMMONIA INHALANTS 10 PER

3 GAUZE BANDAGE, 4" X 6 YD

1 TOURNIQUET AND FORCEPS 1 EA

3 TRIANGULAR BDG, NON-STERILE

1 WIRE SPLINT 1 PER

1 ADH TAPE, .5" X 2.5 YD, 2 PER

3 GAUZE COMPRESS, 1728 SQ IN 1

2 GAUZE COMP, 1 SQ YARD, 1 PER

3 BANDAGE COMP, 2" OFFSET, 4 PER

2 BANDAGE COMP, 4" OFFSET, 1 PER

3 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 FINGERTIP BANDAGE, 10 PER

1 1 OZ EYE WASH W/PADS & STRIPS

1 BURN JEL 1/8 OZ, 6 PER

1 PVP IODINE WIPES 10 PER

1 BIOHAZARD BAG/SCRAPER BBP

1 CPR MICROSHIELD W/2 PR LTX GLV

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 LBL CONTS 8"X8",CUSTOM ID B

1 KIT STL 36 UN WHT 01 HOR SHELF

1 LABL INSTR 24 & 36 UNIT KITS

1 STING RELIEF 10

Principal Display Panel

Inhalant

Burn Jel
Principal Display Panel

Burn Jel

Sting Relief
Principal Display Panel

Sting Relief

PVP
Principal Display Panel

PVP Swab

Neomycin
Principal Display Panel

Neomycin

4218 Kit Label
010424-4224

4218 label

4218 FIRST AID KIT 
4218 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4218
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4218-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 AMPULE 3 mL
Part 26 PACKET 21 g
Part 310 POUCH 4 mL
Part 410 POUCH 3 mL
Part 51 BOTTLE 30 mL
Part 610 PACKET 9 g
Part 1 of 6
AMMONIA INHALENT 
ammonia inhalent inhalant
Product Information
Item Code (Source)NDC:0498-3334
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3334-000.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 2 of 6
BURN JEL 
gel for burns gel
Product Information
Item Code (Source)NDC:0498-0203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0203-003.5 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 finalpart34809/19/2018
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 4 of 6
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
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
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
Part 5 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 6 of 6
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2018
Labeler - Honeywell Safety Products USA, Inc. (079287321)
Registrant - Honeywell Safety Products USA, Inc. (079287321)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4218)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0203, 0498-0730)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical532775194manufacture(0498-0121)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(0498-0733)

Revised: 3/2019
Document Id: 84c2af74-48b1-5f39-e053-2a91aa0acff6
Set id: 84c2af74-48b0-5f39-e053-2a91aa0acff6
Version: 1
Effective Time: 20190323
 
Honeywell Safety Products USA, Inc.