4208 First Aid Kit by Honeywell Safety Products USA, INC 4208 FIRST AID KIT kit

4208 First Aid Kit by

Drug Labeling and Warnings

4208 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]

First Aid Burn Cream Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream Uses

• prevent skin infection
• for temporary relief of pain associated with minor burns

First Aid Burn Cream Warnings

For external use only

Do not use

• in or near the eyes
• if you are allergic to any of the ingredients
• in large areas of the body, particularly over raw surfaces or blistered areas
• for more than 10 days

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

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

First Aid Burn Cream Directions

• adults and children 2 years of age and older:
• clean the affected area
• apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: consult a doctor

First Aid Burn Cream Other information

• tamper evident sealed packets
• do not use if packet is opened or torn

First Aid Burn Cream Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

First Aid Burn Cream Questions

1-800-430-5490

Ammonia Inhalent Active ingredient (in each ampule)

Ammonia 15%

Ammonia Inhalent Purpose

Respiratory stimulant

Ammonia Inhalent Uses

• to prevent or treat fainting

Ammonia Inhalent 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 Inhalent 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

Ammonia Inhalent Other information

• store at room temperature away from light

Ammonia Inhalent Inactive ingredients

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

Ammonia Inhalent 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

PVP Active Ingredient

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

PVP Purpose

First aid antiseptic

PVP Uses

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

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 Directions

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 informatiion

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

PVP Inactive ingredient

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

PVP Questions

1-800-430-5490

4208 019736-0023L Kit Contents

1 KNUCKLE BAND 8 PER

3 FIRST AID BURN CREAM 6 PER

1 AMMONIA INHALANTS 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

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

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

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

2 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 2" OFFSET, 4 PER

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

1 ADH BAND, EXTRA LARGE, 6 PER

2 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 TWEEZER PLASTICS 4"

1 FIRST AID GUIDE ASHI

LBL STOCK 6-3/8"X4"

LBL STOCK 3"x1-7/8"

1 LABEL NORTH CONTENTS 8X8 ID B

1 KIT STL 24 UN WHITE 01

1 LABEL 24U CVR NORTH WELDERS

First Aid Burn Cream Principal Display Panel

Ammonia Inahalent Principal Display Panel

Eyewash Principal Display Panel

PVP Principal Display Panel

4208 Kit Label 019736-0023L

INGREDIENTS AND APPEARANCE

4208 FIRST AID KIT 
4208 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4208

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4208-01	1 in 1 KIT; Type 0: Not a Combination Product	03/14/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	18 PACKET	16.2 g
Part 2	10 AMPULE	3 mL
Part 3	2 BOTTLE	60 mL
Part 4	20 POUCH	6 mL

Part 1 of 4

FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC: 0498-0903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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 not final	part333A	12/20/2017

Part 2 of 4

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 3 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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

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 4

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/14/2019

Labeler - 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(0498-4208)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0903)

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

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