4216 FIRST AID KIT- 4216 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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4216 First Aid Kit (Burn Sp, EW, ASA, amm. Inh, BZK wipe, triple- 34120FP)

Eyewash
Active ingredient

Sterile Water 99%

Eyewash
Purpose

Eyewash

Eyewash
Uses

Eyewash
Warnings

For external use only Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

Do not use

  • if solution changes color or becomes cloudy
  • if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists

Keep out of reach of children

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

Eyewash
Directions

Eyewash
Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash
Questions

1-800-430-5490

Aspirin
Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Aspirin
Purpose

Pain reliever/fever reducer

Aspirin
Uses

temporarily reduces fever and relieves minor aches and pains associated with:

Aspirin
Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are:

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • ringing in the ears or loss of hearing occurs
  • any new symptoms appear

If pregnant or breast-feeding,

If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Keep out of reach of children.

  • In case of overdose, get medical help or contact Poison Control Center right away.

Aspirin
Directions

Aspirin
Other information

Aspirin
Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

*may contain these ingredients

Aspirin
Questions or Comments

1-800-430-5490

Ammonia
Active ingredient

Ammonia 15%

Ammonia
Purpose

Respiratory stimulant

Ammonia
Uses

Ammonia
Warnings

For external use only

Do not use

  • if you have breathing problems such as 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.

Ammonia
Directions

Ammonia
Other information

Ammonia
Inactive ingredient

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

Ammonia
Questions or Comments?

1-800-430-5490

BZK Wipes
Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe
Purpose

First aid antiseptic

BZK Wipes
Uses

BZK Wipes
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

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 Wipe
Directions

BzK Wipe
Other information

BZK Wipe
Inactive ingredient

water

BZK Wipe
Questions

1-800-430-5490

Burn Spray
Active ingredient

Lidocaine HCl 2%

Burn Spray
Purpose


External analgesic

Burn Spray
Uses

Burn Spray
Warnings

For external use only

Do not use

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


When using this product

  • avoid contact with the eyes


Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep out of reach of children

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

Burn Spray
Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Burn Spray
Other information

Burn Spray
Inactive ingredients


diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Burn Spray
Questions or Comments?

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
Purrpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple
Uses

first aid to help prevent infection in

Triple
Warnings

For external use only

Allergy alertdo 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

Triple
Other information

Triple
Inactive ingredient

petrolatum

Triple
Questions?

1-800-430-5490

4216
34120FP Kit Contents

1 3/4 X 3 PLAS 100/BOX

1 1X3 WOVEN SING 50/BOX

1 AMMONIA INHALANTS 10 PER

1 INSTANT COLD PACK 4" X 6"

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

3 GAUZE CLEAN-WRAP BDGE N/S 2"

1 BLOODSTOPPER

1 GZE PADS STERILE 2"X 2" 25'S

1 3" COTTON TIPS 25 PER VIAL

1 ANTISEPTIC WIPES BZK CHL 20'S

2 ASPIRIN IND PK 5 GR 2/ENV 100

1 TRIPLE BIOTIC .5 GRAM PKT 20

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 F A KIT EMPTY BLANK 120

1 TONGUE BLADES SR WRAPPED 6'S

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 TRI BNDG NON WOVEN 40"X40"X56"

10 NON ADHERENT PAD 2" X 3"

Eyesaline

Aspirin
Principal Display Panel

Aspirin

Ammonia
Principal Display Panel

Ammonia Inhalant

BZK Wipe
Principal Display Panel

Antiseptic Wipe

Burn Spray
Principal Display Panel

Burn Spray

Triple
Principal Display Panel

Triple Antibiotic

4216 Kit Label
341420FP

4216 label

4216 FIRST AID KIT 
4216 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4216
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4216-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 PACKET 10 g
Part 21 BOTTLE 118 mL
Part 320 PACKET 28 mL
Part 4100 PACKET 200 
Part 510 AMPULE 3 mL
Part 61 BOTTLE, SPRAY 59 mL
Part 1 of 6
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:0498-0750-360.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 2 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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-02118 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 3 of 6
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 finalpart333E12/21/2017
Part 4 of 6
ASPIRIN 
aspirin tablet
Product Information
Item Code (Source)NDC:0498-0114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0114-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/18/2018
Part 5 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 6 of 6
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2018
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
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4216, 0498-0750)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004manufacture(0498-0114)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0221)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0501)

Revised: 3/2019
Document Id: 84a338c8-de9b-8253-e053-2a91aa0a0e20
Set id: 84a338c8-de9a-8253-e053-2a91aa0a0e20
Version: 1
Effective Time: 20190321
 
Honeywell Safety Products USA, INC