4044 FIRST AID KIT- 4044 first aid kit
4045 FIRST AID KIT- 4045 first aid kit
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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4044, 4045 First Aid Kit (PVP, First Aid Burn Cr- Z019733-0019L, 019733-0020L)

PVP Wipes
Active ingredient

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

PVP Wipes
Purpose

First aid antiseptic

PVP Wipes
Uses

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

PVP Wipes
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 Wipes
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 Wipes
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 Wipes
Inactive ingredients

nonoxynol 9, water

PVP Wipes
Questions

800-430-5490

Burn Cream
Active ingredient

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Burn Cream
Purpose

First aid antiseptic

External analgesic

Burn Cream
Uses

prevent skin infection
for temporary relief of pain associated with miinor burns

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 persists
symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of chidren

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

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 area of the tip of finger) onto the affected area 1 to 3 times daily
may be covered with a sterile bandage
children under 2 years of age: ask a doctor

Burn Cream
Other information

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

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

Burn Cream
Questions

1-800-430-5490

Neomycin
Active ingredient

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

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

first aid to help prevent infection in:

minor cuts
scrapes
burns

Neomycin
Warnings

For external use only

Neomycin
Do not use

in the eyes
over large areas of the body

Neomycin
Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Neomycin
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

Neomycin
Keep out of reach of children

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

Neomycin
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

Neomycin
Other information

Store at 15 o to 25 o C (59 o to 77 oF)

Neomycin
Inactive ingredients

petrolatum

Neomycin
Questions

1-800-430-5490

4044
Z019733-0020L Kit Contents

FIRST AID GUIDE ASHI

GAUZE CLEAN-WRAP BDGE N/S 2"

PVP PREP PADS MEDIUM 100/BX

SCISSOR BDGE 4" RED PLS HDL

FIRST AID CREAM 1.0GR PKT EACH

TAPE ADHESIVE 1/2 X 2.5 125133

POUCH NEOMYCIN ANTIBIOTIC .9 G

ADH BNDG PLASTIC EX-LG 4"X 2"

GAUZE PADS 3"X3" 12PLY

PLASTIC BANDAGE 1" X 3"

4045
019733-0020L Kit Contents

FIRST AID GUIDE ASHI

GAUZE CLEAN-WRAP BDGE N/S 2"

PVP PREP PADS MEDIUM 100/BX

SCISSOR BDGE 4" RED PLS HDL

FIRST AID CREAM 1.0GR PKT EACH

TAPE ADHESIVE 1/2 X 2.5 125133

POUCH NEOMYCIN ANTIBIOTIC .9 G

ADH BNDG PLASTIC EX-LG 4"X 2"

GAUZE PADS 3"X3" 12PLY

PLASTIC BANDAGE 1" X 3"

Honeywell PVP Wipes

Honeywell PVP wipe

Burn Cream
Principal Display Panel

Burn Cream

Neomycin
Principal Display Panel

Neomycin

4044 Kit Label
Z019733-0019L

4044 kit label

4045 Kit Label
019733-0020L

4045 kit label

4044 FIRST AID KIT
4044 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4044

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4044-01	1 in 1 KIT; Type 0: Not a Combination Product	11/21/2018	10/18/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	6 POUCH	1.8 mL
Part 2	4 PACKET	3.6 g
Part 3	1 PACKET	0.9 g

Part 1 of 3

PVP IODINE WIPE
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC:0498-0121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:0498-0121-34	10 in 1 CARTON
1	NDC:0498-0121-00	0.3 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

Part 2 of 3

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Part 3 of 3

NEOMYCIN
antibiotic ointment

Product Information
Item Code (Source)	NDC:0498-0730
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0730-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/31/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/21/2018	10/18/2019

4045 FIRST AID KIT
4045 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4045

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4045-01	1 in 1 KIT; Type 0: Not a Combination Product	11/21/2018	10/18/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	6 POUCH	1.8 mL
Part 2	4 PACKET	3.6 g
Part 3	4 PACKET	3.6 g

Part 1 of 3

PVP IODINE WIPE
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC:0498-0121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:0498-0121-34	10 in 1 CARTON
1	NDC:0498-0121-00	0.3 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

Part 2 of 3

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Part 3 of 3

NEOMYCIN
antibiotic ointment

Product Information
Item Code (Source)	NDC:0498-0730
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0730-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/31/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/21/2018	10/18/2019

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Name	Address	ID/FEI	Business Operations
Establishment
Honeywell Safety Products USA, Inc		079287321	pack(0498-4044, 0498-4045)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(0498-0903, 0498-0730)

Revised: 10/2019

Document Id: 953798bb-e21b-337e-e053-2995a90a0194

Set id: 7badabd5-699f-b850-e053-2a91aa0a2848

Version: 2

Effective Time: 20191018

Honeywell Safety Products USA, Inc

4044, 4045 First Aid Kit (PVP, First Aid Burn Cr- Z019733-0019L, 019733-0020L)

PVP Wipes Active ingredient

PVP Wipes Purpose

PVP Wipes Uses

PVP Wipes Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

PVP Wipes Directions

PVP Wipes Other information

PVP Wipes Inactive ingredients

PVP Wipes Questions

Burn Cream Active ingredient

Burn Cream Purpose

Burn Cream Uses

Burn Cream Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of chidren

Burn Cream Directions

Burn Cream Other information

Burn Cream Inactive ingredients

Burn Cream Questions

Neomycin Active ingredient

Neomycin Purpose

Neomycin Uses

Neomycin Warnings

Neomycin Do not use

Neomycin Ask a doctor before use if you have

Neomycin Stop use and ask a doctor if:

Neomycin Keep out of reach of children

Neomycin Directions

Neomycin Other information

Neomycin Inactive ingredients

Neomycin Questions

4044 Z019733-0020L Kit Contents

4045 019733-0020L Kit Contents

Honeywell PVP Wipes

Burn Cream Principal Display Panel

Neomycin Principal Display Panel

4044 Kit Label Z019733-0019L

4045 Kit Label 019733-0020L

PVP Wipes
Active ingredient

PVP Wipes
Purpose

PVP Wipes
Uses

PVP Wipes
Warnings

PVP Wipes
Directions

PVP Wipes
Other information

PVP Wipes
Inactive ingredients

PVP Wipes
Questions

Burn Cream
Active ingredient

Burn Cream
Purpose

Burn Cream
Uses

Burn Cream
Warnings

Burn Cream
Directions

Burn Cream
Other information

Burn Cream
Inactive ingredients

Burn Cream
Questions

Neomycin
Active ingredient

Neomycin
Purpose

Neomycin
Uses

Neomycin
Warnings

Neomycin
Do not use

Neomycin
Ask a doctor before use if you have

Neomycin
Stop use and ask a doctor if:

Neomycin
Keep out of reach of children

Neomycin
Directions

Neomycin
Other information

Neomycin
Inactive ingredients

Neomycin
Questions

4044
Z019733-0020L Kit Contents

4045
019733-0020L Kit Contents

Burn Cream
Principal Display Panel

Neomycin
Principal Display Panel

4044 Kit Label
Z019733-0019L

4045 Kit Label
019733-0020L