4220 FIRST AID KIT- 4220 first aid kit

4220 First Aid Kit by

Drug Labeling and Warnings

4220 First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Burn Jel Active ingredient

Lidocaine HCl 2.0%

Burn Jel Purpose

External analgesic

Burn Jel Uses

• temporarily relieves pain due to minor burns

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

• 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
• you may report a serious reaction to this product to 800-430-5490

Burn Jel Other information

• store at room temperature - do not use if opened or torn

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

• adults and children 2 years and older:
• apply to cleaned affected area not more than 3 times daily.
• children under 2 years of age: consult a doctor.

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

• first aid to help prevent the risk of infection in minor cuts, scrapes, and burn

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.

• clean affected area
• apply to affected area 1 to 3 times daily
• may be covered with a sterile bandage
• discard swab after single use

PVP Other information

• store at room temperature away from light
• keep from freezing or excessive heat
• do not use if package is torn or open

PVP Inactive ingredients

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

PVP Questions and Comments?

1-800-430-5490

Alcohol Active ingredient

Isopropyl alcohol 70%

Alcohol Purpose

First aid antiseptic

Alcohol Uses

first aid to help prevent infection in minor cuts, scrapes, and burns

Keep out of the reach of children

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

Alcohol Warnings

For external use only

Flammable, keep away from fire and flame

Do not use

• in or near eyes
• over large areas of the body

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 1 week unless directed by a doctor

Stop use and consult a doctor if

• condition persists or gets worse

Alcohol Directioons

• clean the affected area
• may be covered with a sterile bandage
• apply wipe to affeted are 1 to 3 times daily
• discard wipe after single use

Alcohol Other information

• store at room temperature 15 o to 25 o C (59 o to 77 oF)
• do not use if packet is torn or opened

Alcohol Inactive ingredient

water

Neomycin Active ingredient

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 0 to 25 0 C (59 0 to 77 0 F)

Neomycin Inactive ingredient

petrolatum

Neomycin Questions?

1-800-430-5490

Eyewash Active ingredient

Sterile Water 99%

Eyewash Purpose

Eyewash

Eyewash Uses

• for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

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

• remove contacts before using
• twist top to remove
• flush the affected area as needed
• control rate of flow by pressure on the bottle
• if necessary, continue flushing with emergency eyewash or shower

Eyewash Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash Questions?

1-800-430-5490

4220 019643-4367 Kit Contents

1 KNUCKLE BAND 8 PER

1 NEOMYCIN ANTIBIOTIC 10 PER

1 GAUZE BANDAGE, 4" X 6 YD

2 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 3" X 3", 4 PER

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

2 INSTANT COLD PACK 4" X 6"

2 BANDAGE COMP, 2" OFFSET, 4 PER

2 BANDAGE COMP, 4" OFFSET, 1 PER

2 ADH BAND, EXTRA LARGE, 6 PER

2 1 OZ EYE WASH W/PADS & STRIPS

1 BURN JEL 1/8 OZ, 6 PER

5 WATER JEL DRESSING,2" X 6"

1 PVP IODINE WIPES 10 PER

2 NITRILE GLOVES 2PR BBP

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

1 FIRST AID GUIDE ASHI

2 ABD COMBINE PAD 5" X 9"

1 MICROSHIELD W/VNL GLV/ALCL

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"

1 STOCK LABEL 1 7/8" X 1/2"

1 LBL CONTS 8"X8",CUSTOM ID B

1 KIT 36 UNIT PLASTIC

1 STING Relief WIPES 10

Burn Jel Principal Display Panel

Sting Relief Principal Display Panel

PVP Principal Display Panel

Alcohol Principal Display Panel

Neomycin Principal Display Panel

Eyewash Principal Display Panel

4220 Kit Label 019643-4367

INGREDIENTS AND APPEARANCE

4220 FIRST AID KIT 
4220 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4220

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4220-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	21 g
Part 2	10 POUCH	4 mL
Part 3	10 POUCH	3 mL
Part 4	2 BOTTLE	60 mL
Part 5	10 PACKET	9 g
Part 6	1 POUCH	0.4 mL

Part 1 of 6

BURN JEL 
gel for burns gel

Product Information
Item Code (Source)	NDC: 0498-0203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0203-00	3.5 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	part348	09/19/2018

Part 2 of 6

STING RELIEF PAD 
ethyl alcohol, lidocaine swab

Product Information
Item Code (Source)	NDC: 0498-0733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0733-00	0.4 mL in 1 POUCH; 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	part348	12/23/2017

Part 3 of 6

PVP IODINE WIPE 
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC: 0498-0121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0121-00	0.3 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/18/2018

Part 4 of 6

EYESALINE EMERGENCY EYEWASH 
purified water liquid

Product Information
Item Code (Source)	NDC: 0498-0100
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/18/2018

Part 5 of 6

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 6 of 6

ALCOHOL WIPE 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 0498-0143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0143-04	0.4 mL in 1 POUCH; 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	09/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/13/2018

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(0498-4220)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0203, 0498-0730)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc.		167518617	manufacture(0498-0100)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical		421317073	manufacture(0498-0143)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical		532775194	manufacture(0498-0121)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(0498-0733)