4363 FIRST AID KIT- 4363 first aid kit

4363 First Aid Kit by

Drug Labeling and Warnings

4363 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]

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

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

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

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

Keep out of the reach of children

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

Alcohol Directions

• 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 0 to 25 0 C (59 0 to 77 0 F)
• do not use if packet is torn or

Alcohol Questions

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

4363 SF00003199 kit contents

1 1 X 3 WOVEN 100/BOX

1 KNUCKLE BAND 8 PER

2 TRIPLE ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 TRIANGULAR BDG, NON-STERILE

4 GAUZE COMPRESS, 1728 SQ IN 1

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

2 INSTANT COLD PACK 4" X 6"

2 PAD,NON-ADHR 2" X 3", 4 PER

1 ALCOHOL PREP PADS 10P

2 STING RELIEF WIPES 10 PER BOX

2 NITRILE GLOVES 2PR BBP

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

1 FIRST AID GUIDE ASHI

1 NON-ADHERENT PADS 2"X3" 10'S

2 COHESIVE TAPE GRN 3/4X30

1 ELASTIC BANDAGE 3" X 4.5YD

1 CO-FLEX LATEX FREE 3"X5YD TAN

1 CTA 3" SINGLE TIP 100/PER

1 CPR MICROSHIELD W/2 PR LTX GLV

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 SPLINTER FORCEP 4 1/2"

1 F A KIT EMPTY BLANK 140

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

Triple Principal Display Panel

Sting Relief Principal Display Panel

Alcohol Principal Display Panel

Eyewash Principal Display Panel

4363 Kit Label SF00003199

INGREDIENTS AND APPEARANCE

4363 FIRST AID KIT 
4363 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4363

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4363-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	20 PACKET	18 g
Part 3	10 POUCH	4 mL
Part 4	20 POUCH	8 mL

Part 1 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: 0498-0100-02	118 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 2 of 4

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 3 of 4

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

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(0498-4363)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(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(0498-0143)

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