4314 FIRST AID KIT- 4314 first aid 
4315 FIRST AID KIT- 4315 first aid 
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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4314, 4315 First Aid Kit (Triple, EW, BZK wipe, antiseptic hand gel- SF00004528, SF00004529)

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:

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

Triple
Inactive ingredient

petrolatum

Triple
Questions?

1-800-430-5490

BZK Wipe
Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe
Purpose

First aid antiseptic

BzK Wipe
Uses

Antiseptic cleansing of face, hands, and body without soap and water

BZK Wipe
Warnings


For external use only

Do not use

  • in the eyes or over large areas of the body
  • on mucous membranes
  • on irritated skin
  • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
  • longer than 1 week unless directed by a doctor


Stop use and ask a doctor if

  • if irritation, redness or other symptoms develop
  • the condition persists or gets worse

Keep out of reach of children

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

BZK Wipe
Directions

tear open packet and use as a washcloth

BZK Wipe
Other information

BZK Wipe
Inactive ingredient

water

BZK Wipe
Questions

1-800-430-5490

Eyewash
Active ingredient

Sterile Water 99%

Eyewassh
Purpose

Eyewash

Eyewash
Uses

Eyewash
Warnings

For external use only

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

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

Hand Sanitizer
Active ingredient

Ethyl alcohol 62%

Hand Sanitizer
Purpose

Antiseptic handwash

Hand Sanitizer
Uses

Hand Sanitizer
Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

  • do not use in the eyes
  • discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

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

Hand Sanitizer
Directions

wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer
Other information

Hand Sanitizer
Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer
Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

4314
Sf00004528 Kit Contents

1 1X3 PLASTIC 100/BOX

1 TRIPLE ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 TRIANGULAR BDG, NON-STERILE

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

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

1 INSTANT COLD PACK 4" X 6"

1 BUFFERED EYE WASH 1 OZ BTL

1 WATER JEL DRESSING 4" X 4"

2 TOPICAL COOLING JEL

1 NITRILE GLOVES 2PR BBP

1 ANTIMCRBL ANTSPTC TWLETTS

1 ADHES TAPE W/P 1"X 2 1/2 YD

1 1FIRST AID GUIDE ASHIEMERGENCY SURVIVAL BLANKET

1 HAND SANITIZER 0.9G WJ 25/BX

2 BLOODSTOPPER

1 CPR FILTERSHIELD 77-100

1 F A KIT EMPTY BLANK 140

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 SCISSORS ANGLED 1EA IN BAG

4315
SF00004529 kit contents

1 1X3 PLASTIC 100/BOX

3 TRIPLE ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 GAUZE BANDAGE, 4" X 6 YD

1 TOURNIQUET AND FORCEPS 1 EA

2 TRIANGULAR BDG, NON-STERILE

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

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

2 INSTANT COLD PACK 4" X 6"

2 WATER JEL DRESSING 4" X 4"

5 TOPICAL COOLING JEL

2 NITRILE GLOVES 2PR BBP

5 ANTIMCRBL ANTSPTC TWLETTS

2 ADHES TAPE W/P 1"X 2 1/2 YD

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

1 HAND SANITIZER 0.9G WJ 25/BX

4 BLOODSTOPPER

1 CPR FILTERSHIELD 77-100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 180 EMPTY BLANK NO LOGO

1 SAM SPLINT 4.5"X36" ORNGE/BL

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 SCISSORS ANGLED 1EA IN BAG

Triple
Principal Display Panel

Triple Antibiotic

BZK Wipe
Principal Display Panel

Antiseptic Wipe

Eyewash
Principal Display Panel

Eyesaline

Hand Sanitizer
Principal Display Panel

Hand Sanitizer

4314 Kit Label
SF00004528

4314 label

4315 Kit Label
SF00004529

4315 label

4314 FIRST AID KIT 
4314 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4314
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4314-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 210 PACKET 9 g
Part 31 PACKET 1.4 mL
Part 425 BOTTLE, PLASTIC 22.5 mL
Part 1 of 4
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, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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 4
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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 3 of 4
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/22/2017
Part 4 of 4
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2018
4315 FIRST AID KIT 
4315 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4315
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4315-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 230 PACKET 27 g
Part 35 PACKET 7 mL
Part 425 BOTTLE, PLASTIC 22.5 mL
Part 1 of 4
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, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-02118 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 4
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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 3 of 4
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/22/2017
Part 4 of 4
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2018
Labeler - Honeywell Safety Products USA, Inc. (079287321)
Registrant - Honeywell Safety Products USA, Inc. (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4314, 0498-4315)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0750, 59898-420)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Maokang Medical421317073manufacture(0498-0501)

Revised: 5/2019
Document Id: 88943ce9-fd4e-6678-e053-2995a90af0ba
Set id: 889424aa-17a4-34d2-e053-2995a90a12f5
Version: 1
Effective Time: 20190510
 
Honeywell Safety Products USA, Inc.