4200 FIRST AID KIT- 4200 first aid kit 
4202 FIRST AID KIT- 4202 first aid kit 
4201 FIRST AID KIT- 4201 first aid kit 
4255 FIRST AID KIT- 4255 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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4200, 4201, 4202, 4255 First Aid Kit (FABC, EW, triple, PVP wipes, Sting relief- 019713-0007L,019714-0008L, 019715-0008L, Z019714-0008L)

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

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

First Aid Burn Cream
Other information

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

Eyewash
Active ingredient

Sterile Water 99%

Eyewash
Purpose

Eyewash

Eyewash
Uses

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

Eyewash
Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyewash
Questions

1-800-430-5490

Triple
Active ingredient (each gram contains)

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

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

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
Purpose

Antiseptic-Topical pain relief

Sting Relief
Uses

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

Sting Relief
Inactive ingredients

benzalkonium chloride, menthol, and purified water

Questions or Comments?

1-800-430-5490

PVP
Active ingredient

Povidone-iodine 10% (equivalent to 1% titratable iodine)

PVP
Purpose

First aid antiseptic

PVP
Uses

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 helpor contact a Poison Control Center right away.

PVP
Directions

PVP
Other information

PVP
Inactive ingredients

nonoxynol 9, water

PVP
Questions

1-800-430-5490

4200
019713-0007L Kit Contents

1 KNUCKLE BAND 8 PER

1 TRIPLE ANTIBIOTIC 10 PER

2 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

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

1 ADH TAPE, .5" X 2.5 YD, 2 PER

1 FORCEPS & SCISSORS, 1 EA

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

1 GAUZE COMP, 1 SQ YARD, 1 PER

1 INSTANT COLD PACK 4" X 6"

1 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

1 FINGERTIP BANDAGE, 10 PER

2 PVP IODINE WIPES 10 PER

2 NITRILE GLOVES 2PR BBP

1 FIRST AID GUIDE ASHI

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 LABEL NORTH CONTENTS 8X8 ID B

1 KIT STL 24 UN WHITE 01

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 BBL 24U CVR NORTH ID C

1 STING Relief WIPES 10

4201
019714-0008L Kit Contents

2 KNUCKLE BAND 8 PER

1 TRIPLE ANTIBIOTIC 10 PER

2 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

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

2 ADH TAPE, .5" X 2.5 YD, 2 PER

1 FORCEPS & SCISSORS, 1 EA

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

2 GAUZE COMP, 1 SQ YARD, 1 PER

2 INSTANT COLD PACK 4" X 6"

2 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 3" OFFSET, 2 PER

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

2 FINGERTIP BANDAGE, 10 PER

2 PVP IODINE WIPES 10 PER

2 NITRILE GLOVES 2PR BBP

1 FIRST AID GUIDE ASHI

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 LABEL NORTH CONTENTS 8X8 ID B

1 KIT 36 UNIT PLASTIC

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 LBL 36U CVR NORTH ID C.

2 STING Relief WIPES 10

4202
019715-0008L Kit Contents

2 KNUCKLE BAND 8 PER

2 TRIPLE ANTIBIOTIC 10 PER

2 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

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

2 ADH TAPE, .5" X 2.5 YD, 2 PER

1 FORCEPS & SCISSORS, 1 EA

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

2 GAUZE COMP, 1 SQ YARD, 1 PER

2 INSTANT COLD PACK 4" X 6"

2 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 3" OFFSET, 2 PER

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

2 FINGERTIP BANDAGE, 10 PER

2 PVP IODINE WIPES 10 PER

2 NITRILE GLOVES 2PR BBP

1 FIRST AID GUIDE ASHI

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 LABEL NORTH CONTENTS 8X8 ID B

1 KIT STL 36 UN WHT 01 HOR SHELF

1 LBL CONTENTS ANSI Z308.1-2009 REV B

1 LBL 36U CVR NORTH ID C.

1 NOX A STING WIPES 10

4255
Z019714-0008L kit contents

2 KNUCKLE BAND 8 PER

1 TRIPLE ANTIBIOTIC 10 PER

2 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

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

2 ADH TAPE, .5" X 2.5 YD, 2 PER

1 FORCEPS & SCISSORS, 1 EA

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

2 GAUZE COMP, 1 SQ YARD, 1 PER

2 INSTANT COLD PACK 4" X 6"

2 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 3" OFFSET, 2 PER

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

2 FINGERTIP BANDAGE, 10 PER

2 PVP IODINE WIPES 10 PER

2 STING RELIEF WIPES 10 PER BOX

2 NITRILE GLOVES 2PR BBP

1 FIRST AID GUIDE ASHI

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 36 UNIT PLASTIC

First Aid Burn Cream
Principal Display Panel

First Aid Burn Cream

Eyewash
Principal Display Panel

Eyewash Label

Triple
Principal Display Panel

Triple Antibiotic

Sting Relief
Principal Display Panel

Sting Relief

PVP
Principal Display Panel

PVP Swab

4200 Kit Label
019713-0007L

4200 Kit Label

4201 KIT LABEL
019714-0008L

4201 Kit Label

4202 Kit Label
019715-0008L

4202 Kit Label

4255 Kit Label
Z019714-0008L

4255 label

4200 FIRST AID KIT 
4200 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4200
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4200-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 212 PACKET 10.8 g
Part 310 PACKET 9 g
Part 410 POUCH 4 mL
Part 520 POUCH 6 mL
Part 1 of 5
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 2 of 5
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 3 of 5
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 4 of 5
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 5 of 5
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4202 FIRST AID KIT 
4202 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4202
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4202-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 112 PACKET 10.8 g
Part 22 BOTTLE 60 mL
Part 320 PACKET 18 g
Part 410 POUCH 4 mL
Part 520 POUCH 6 mL
Part 1 of 5
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 5
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 3 of 5
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 4 of 5
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 5 of 5
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4201 FIRST AID KIT 
4201 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4201
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4201-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 112 PACKET 10.8 g
Part 22 BOTTLE 60 mL
Part 310 PACKET 9 g
Part 420 POUCH 8 mL
Part 520 POUCH 6 mL
Part 1 of 5
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 5
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 3 of 5
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 4 of 5
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 5 of 5
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4255 FIRST AID KIT 
4255 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4255
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4255-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 112 PACKET 10.8 g
Part 22 BOTTLE 60 mL
Part 310 PACKET 9 g
Part 420 POUCH 8 mL
Part 520 POUCH 6 mL
Part 1 of 5
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/20/2017
Part 2 of 5
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/18/2018
Part 3 of 5
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 4 of 5
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0733-000.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/23/2017
Part 5 of 5
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
Labeler - Honeywell Safety Products USA, INC (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, INC079287321pack(0498-4200, 0498-4201, 0498-4202, 0498-4255)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0903, 0498-0750)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Sion Medical Biotext532775194manufacture(0498-0121)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America Inc874965262manufacture(0498-0733)

Revised: 4/2019
Document Id: 860d8c6e-2230-6970-e053-2991aa0ab91a
Set id: 83efc1f3-e035-6e8d-e053-2991aa0ad1aa
Version: 2
Effective Time: 20190408
 
Honeywell Safety Products USA, INC