4155 FIRST AID KIT- 4155 first aid kit

4155 First Aid Kit by

Drug Labeling and Warnings

4155 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]

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

• hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated on sleeve.
• hold near nostrils for inhalation of volatile vapor

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

• 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

Triple Active ingredient

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Triple Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple Uses

first aid to help prevent infection in:

• minor cuts
• scrapes
• burns

Triple Warnings

For external use only

Allergy alert: do 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

• 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

Triple Other information

• store at 15 0 to 25 0 C (59 0 to 77 0 F)
• tamper evident sealed packets
• do not use if packet is torn or opened

Triple Inactive ingredient

petrolatum

Triple 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 Other information

water

BZK Wipe Questions

1-800-430-5490

Antishitamine Active ingredient (in each tablet)

Diphenhydramine HCl (25 mg)

Antihistamine Purpose

Antihistamine

Antihistamine Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

• runny nose
• sneezing
• itchy, watery eyes, itching of the nose or throat

Antihistamine Warnings

Do not use

• with any other product containing diphenhydramine, even one used on the skin

Ask a doctor before use if you have

• glaucome
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use

• if child is taking a sedative or tranquilizer
• When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breast-feeding

• ask a health professional before use

Keep out of the reach of children

Antihistamine Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets) not to exceed 300 mg in 24 hours

children 6 to under 12 years of age 12.5 mg** to 25 mg (1 tablet) not to exceed 150mg in 24 hours or as directed by a doctor

children under 6 years of age ask a doctor

**12.5 mg dosage strength is not available in this package
do not attempt to break tablets

Antihistamine Inactive ingredients

carnuba wax, colloidal silicon dioxide, croscarmellose sodium D and C red no. 27 lake, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

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

Honeywell Safety Products USA, Inc. Smithfield, RI 02917

4155 SF00000981 Kit Contents

1 TRIPLE ANTIBIOTIC 10 PER

1 AMMONIA INHALANTS 10 PER

2 TRIANGULAR BDG, NON-STERILE

1 GAUZE COMPRESS, 1728 SQ IN 1

1 GAUZE BANDAGE, 2" X 6 YD,2 PER

1 INSTANT COLD PACK 4" X 6"

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

1 1 OZ EYE WASH W/PADS & STRIPS

1 BURN JEL 1/8 OZ, 6 PER

3 ANTIMCRBL ANTSPTC TWLETTS

1 FIRST AID GUIDE ASHI

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 BANDAGE COMP 2" W/TELFA PAD 4

2 BANDAGE COMP 4" W/TELFA PAD 1

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 WOVEN KNUCKLE 8'S

1 ADHS TAPE .5"X2.5YD 2

1 GAUZE PADS 3"X3" 4/BX

1 ANTIHISTAMINE BULK 1/PKK

Principal Display Panel

Burn Jel Principal Display Panel

Triple Principal Display Panel

BZK Wipe Principal Display Panel

Antihistamine Principal Display Panel

Eyewassh Principal Display Panel

4155 Kit Label SF00000981

INGREDIENTS AND APPEARANCE

4155 FIRST AID KIT 
4155 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4155

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4155-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 AMPULE	3 mL
Part 2	6 PACKET	21 g
Part 3	1 BOTTLE	30 mL
Part 4	10 PACKET	9 g
Part 5	3 PACKET	4.2 mL

Part 1 of 5

AMMONIA INHALENT 
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC: 0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-3334-00	0.3 mL in 1 AMPULE; 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 2 of 5

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 3 of 5

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 4 of 5

TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Item Code (Source)	NDC: 0498-0750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0750-35	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	09/19/2018

Part 5 of 5

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

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
James Alexander		040756421	manufacture(0498-3334)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	pack(0498-4155)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0203, 0498-0750)

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)