4130 FIRST AID KIT- 4130 first aid kit 
4294 FIRST AID KIT- 4294 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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4130, 4294 First Aid Kit (EW, PVP wipes, Sting relief- SF00004222, SF00004164)

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

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

4130
SF00004222 kit contents

2 TRIANGULAR BDG, NON-STERILE

1 GAUZE COMPRESS, 1728 SQ IN 1

1 BUFFERED EYE WASH 1 OZ BTL

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

1 TWEEZER PLASTICS 4"

1 CPR MICROSHIELD DOUBLE UNIT

1 SCISSOR BDGE 4" RED PLS HDL

2 BANDAGE COMP 2" W/TELFA PAD 4

1 BANDAGE COMP 3" W/TELFA PAD 2

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

1 KIT STL 16 UN (VERTICAL)

1 WOVEN KNUCKLE 8'S

2 PVP IODINE SWABS 10

4294
SF00004164 Kit Contents

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE COMPRESS, 1728 SQ IN 1

1 BANDAGE COMP, 2" OFFSET, 4 PER

1 BANDAGE COMP, 3" OFFSET, 2 PER

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

1 FINGERTIP BANDAGE, 10 PER

1 1 OZ EYE WASH W/PADS & STRIPS

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 CPR MICROSHIELD DOUBLE UNIT

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 10 UN WHITE 01

1 LABL INSTR FA REV A

1 44 LABL FILL 10 UN XCEL ENERGY

Eyewash
Principal Display Panel

Eyewash Label

PVP
Principal Display Panel

PVP Swab

4130 Kit Label
SF00004222

4130 label

4294 Kit Label
SF00004164

4294 label

4130 FIRST AID KIT 
4130 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4130
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4130-011 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 220 POUCH 6 mL
Part 1 of 2
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 2
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
4294 FIRST AID KIT 
4294 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4294
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4294-011 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 210 POUCH 3 mL
Part 1 of 2
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 2
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(0498-4294, 0498-4130)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc.167518617manufacture(0498-0100)
Establishment
NameAddressID/FEIBusiness Operations
Sion Medical Biotext532775194manufacture(0498-0121)

Revised: 5/2019
Document Id: 882b65be-ec94-6fd7-e053-2995a90a4dc5
Set id: 8781f56d-1177-0df3-e053-2a95a90a8971
Version: 2
Effective Time: 20190505
 
Honeywell Safety Products USA, INC