4184 FIRST AID KIT- 4184 first aid kit

4184 First Aid Kit by

Drug Labeling and Warnings

4184 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

BZK Wipe Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe Purpose

First aid antiseptic

BzK Wipe Uses

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

BZK Wipe 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

tear open packet and use as a washcloth

BZK Wipe Other information

• store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
• do not reuse towelette

BZK Wipe Inactive ingredient

water

BZK Wipe Questions

1-800-430-5490

Sting Relief Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief Purposse

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 ingredients

benzalkonium chloride, menthol, and purified water

Sting Relief Questions or Comments?

1-800-430-5490

Eyewash Active ingredient

Sterile Water 99%

Eyewassh 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.

Eyeash 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

Eyeash Questions

Call 1-800-430-5490 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

4184 010019-4320 Kit Contents

1 GAUZE BANDAGE, 4" X 6 YD

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 4" X 4", 2 PER

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

1 INSTANT COLD PACK 4" X 6"

1 1 OZ EYE WASH W/PADS & STRIPS

1 BANDAGE COMBO PACK

1 BURN JEL 1/8 OZ, 6 PER

1 IVYX CLEANSER TOWEL 5 PER

1 BIOHAZARD BAG,WIPES/TOWELS BBP

1 NITRILE GLOVES 2PR BBP

1 ANTIMCRBL ANTSPTC TWLETTS

1 COMPRESS, 8" X 10", 1 PER

2 CPR MICROSHIELD W/2 PR LTX GLV

LBL STOCK 6-3/8"X4"

1 LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 24 UN WHITE 01

1 LABL INSTR 24 & 36 UNIT KITS

1 STING Relief WIPES 10

Burn Jel Principal Display Panel

BZK Wipe Principal Display Panel

Sting Relief Principal Display Panel

Eyewash Principal Display Panel

4184 Kit Label 010019-4320

INGREDIENTS AND APPEARANCE

4184 FIRST AID KIT 
4184 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4184

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4184-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	21 g
Part 2	1 BOTTLE	30 mL
Part 3	2 PACKET	2.8 mL
Part 4	10 POUCH	4 mL

Part 1 of 4

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 4

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 3 of 4

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: 0498-0501-00	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	12/22/2017

Part 4 of 4

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

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(0498-4184)

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

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(0498-0501)

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