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

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 helpor 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

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4130

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4130-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	30 mL
Part 2	20 POUCH	6 mL

Part 1 of 2

EYESALINE EMERGENCY EYEWASH
purified water liquid

Product Information
Item Code (Source)	NDC:0498-0100
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.6 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	12/18/2018

Part 2 of 2

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	Marketing Start Date	Marketing End Date
Packaging
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

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

4294 FIRST AID KIT
4294 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4294

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4294-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	30 mL
Part 2	10 POUCH	3 mL

Part 1 of 2

EYESALINE EMERGENCY EYEWASH
purified water liquid

Product Information
Item Code (Source)	NDC:0498-0100
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.6 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	12/18/2018

Part 2 of 2

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	Marketing Start Date	Marketing End Date
Packaging
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

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

Labeler - Honeywell Safety Products USA, INC (118768815)

0498-4130 & 0498-4294: First Aid Kit (EW, PVP wipes, Sting relief- SF00004222, SF00004164)

Eyewash Active ingredient

Eyewash Purpose

Eyewash Uses

Eyewash Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children

Eyewash Directions

Eyewash Inactive ingredients

Eyewash Questions

PVP Active ingredient

PVP Purpose

PVP Uses

PVP Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

PVP Directions

PVP Other information

PVP Inactive ingredients

PVP Questions

4130 SF00004222 kit contents

4294 SF00004164 Kit Contents

Eyewash Principal Display Panel

PVP Principal Display Panel

4130 Kit Label SF00004222

4294 Kit Label SF00004164

Eyewash
Active ingredient

Eyewash
Purpose

Eyewash
Uses

Eyewash
Warnings

Eyewash
Directions

Eyewash
Inactive ingredients

Eyewash
Questions

PVP
Active ingredient

PVP
Purpose

PVP
Uses

PVP
Warnings

PVP
Directions

PVP
Other information

PVP
Inactive ingredients

PVP
Questions

4130
SF00004222 kit contents

4294
SF00004164 Kit Contents

Eyewash
Principal Display Panel

PVP
Principal Display Panel

4130 Kit Label
SF00004222

4294 Kit Label
SF00004164