4399 FIRST AID KIT- 4399 first aid kit

4399 First Aid Kit by

Drug Labeling and Warnings

4399 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

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

Ask a doctor before use if you have

• a deep or puncture wounds
• animal bites
• serious burns

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

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

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

PAWS Active ingredient

Ethyl alcohol 66.5%

PAWS Purpose

Antiseptic

PAWS Uses

• for handwashing to decrease bacteria on skin whenever soap and water is not readily available

PAWS Warnings

For external use only

Flammable: keep away from fire or flame

Do not use

• in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

• irritation or redness develop and persists for more than 72 hours

Keep out of reach of children

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

PAWS Directions

• wet hands and wrists thoroughly for 15 seconds and allow to air dry
• always reseal after use
• children under 6 years of age should be supervised when using this product

PAWS Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Paws Questions

1-800-430-5490

Alcohol Wipe Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe Purpose

First aid antiseptic

Alcohol Wipe Uses

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

Alcohol Wipe Warnings

For external useonly

Flammable, keep away from fire or flame.

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

When using this product

• do not use longer than one week unless directed by a doctor

Keep out of reach of children

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

Stop use and ask a doctor

• if condition persists or gets worse

Alcohol Wipe Directions

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

Alcohol Wipe Other information

• store at room temperature 15 o to 25 o C (59 o to 77 o F)

Alcohol Wipe Inactive ingredients

water

Alcohol Wipe Questions?

1-800-430-5490

PVP Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

PVP Purpose

First aid antiseptic

PVP Uses

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

PVP Warnings

For external use only.

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 or persists for more than 72 hours
• 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

• clean the affected area
• apply1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first
• discard wipe after single use

PVP Other information

• do not use on individuals who are allergic or sensitive to iodine
• store at controlled temperature 59-86ºF (15-30ºC)
• do not use if pouch is open or torn

PVP Inactive ingredients

nonoxynol 9, water

PVP Questions

800-430-5490

4399 68203 Kit Contents

1 TRIPLE ANTIBIOTIC 10 PER

1 ALCOHOL PREP PADS 10P

1 PVP IODINE WIPES 10 PER

1 ADHESIVE TAPE W/P 1/2"X10YDS

1 ADHESIVE TAPE W/P 1" X 10YDS

2 BK GZ 4.5"X4.1YD6PLY RL ST MSO

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

2 GAUZE CLEAN-WRAP BDGE N/S 3"

2 GAUZE CLEAN-WRAP BDGE N/S 4"

2 BLOODSTOPPER

2 ABD COMBINE PAD 5" X 9"

1 MULTI-TRAUMA DRESSING 12"X30"

1 ELASTIC BANDAGE 3" X 4.5YD

1 ELASTIC BANDAGE 4" X 4.5YD

10 PAWS PERS ANTIMICRO WIPE

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

LBL STOCK 3"x1-7/8"

1 LBL STOCK PLAIN 3.2"x7/8"

10 PR NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

1 DRESSING PETROLATUM GAUZE

2 TRI BNDG NON WOVEN 40"X40"X56"

4 EYE PADS STD OVAL STERILE

10 GAUZE PADS 3"X3" 12PLY

20 GAUZE PADS 4"X4" 12PLY

1 ZIP LOCK BAG 13 X 15 1.5 MIL

Triple Antibiotic label

Eyewash

PAWS label

Alcohol Wipe Principal Display Panel

PVP Principal Display Panel

4399 kit label 68203

INGREDIENTS AND APPEARANCE

4399 FIRST AID KIT 
4399 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4399

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4399-01	1 in 1 KIT	09/13/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 POUCH	3 mL
Part 2	1 BOTTLE	118 mL
Part 3	10 PACKET	9 g
Part 4	10 POUCH	4 mL
Part 5	10 PACKET	0.019 L

Part 1 of 5

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
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)

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 2 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: 0498-0100-02	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 3 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 4 of 5

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 5 of 5

PAWS 
ethyl alcohol liquid

Product Information
Item Code (Source)	NDC: 0498-3111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	665 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.0019 L 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	12/21/2017

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(0498-4399)

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
Sion mewdical Biotext		532775194	manufacture(0498-0121)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc		874965262	manufacture(0498-3111)