4316 FIRST AID KIT- 4316 first aid kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
Eyewash - for flushing the eye to remove loose foreign material, air pollutants or chlorinated water First aid antiseptic - first aid to help prevent the risk of infection in minor cuts, scrapes, and burns First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns First aid antibiotic - first aid to help prevent infection in - minor cuts - scrapes - burns - in the eyes - over large areas of the body First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes and burns
Authorization status:
unapproved drug other
Authorization number:
0498-0100-02, 0498-0121-00, 0498-0143-04, 0498-0402-59, 0498-0730-01, 0498-4316-01

4316 FIRST AID KIT- 4316 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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4316 First Aid Kit (Neomycin, EW, PVP wipes, alcohol wipes, Antiseptic Spray- SF00004530)

Eyesaline

Active ingredient

Sterile Water 99%

Eyesaline

Purpose

Eyewash

Eyesaline

Uses

for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyesaline

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.

Eyesaline

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

Eyesaline

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline

Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Povidone Iodine Swab

Active ingredient

Povidone-iodine solution USP, 10% (equivalent to 1% titratable iodine)

Povidone Iodine Swab

Purpose

First aid antiseptic

Povidone Iodine Swab

Uses

first aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Povidone Iodine Swab

Warnings

For external use only

Do not use

over large areas of the body

on individuals who are allergic or sensitive to iodine

Ask a doctor before use if you have

deep or puncture wounds,

animal bites

serious burns

When using this product

do not use longer than one wek unless directed by a doctor

Stop use and ask a doctor if

conditions persists or gets worse

irritation and redness develops

Keep out of reach of children

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

Povidone Iodine Swab

Directions

Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate

tip and apply solution to injury.

clean affected area

apply to affected area 1 to 3 times daily

may be covered with a sterile bandage

discard swab after single use

Povidone Iodine Swab

Other information

store at room temperature away from light

keep from freezing or excessive heat

do not use if package is torn or open

Povidone Iodine Swab

Inactive ingredients

citric acid, disodium phosphate,nonoxynol-9, sodium hydroxide, water

Povidone Iodine Swab

Questions and comments

1-800-430-5490

Alcohol Wipe

Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe

Purpose

First aid antiseptic

Alcohol Wipe

Uses

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

Alcohol Wipe

Warnings

For external use only

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burn

When using this product

do not use longer than one week unless directed by a doctor

Stop use and consult a doctor

if condition persists or gets worse

Keep out of reach of children

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

Alcohol Wipe

Directions

clean the affected area

apply wipe to affected area 1 to 3 times daily

may be covered with a sterile bandage

discard wipe after single use

Alcohol Wipe

Other information

store at room temperature 15

to 25

C (59

to 77

Alcohol Wipe

Inactive ingredient

water

Alcohol Wipe

Questions

1-800-430-5490

Neomycin

Active ingredient

Neomycin 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

Do not use

in the eyes

over large areas of the body

Neomycin

Warnings

For external use only

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

a rash or other allergic reaction develops

you need to use longer than 1 week

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 reach of children

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

Neomycin

Direction

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

to 25

C (59

to 77

Neomycin

Inactive ingredient

petrolatum

Neomycin

Questions?

1-800-430-5490

Antiseptic Spray

Purpose

First aid antiseptic

Antiseptic Spray

Uses

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

Antiseptic Spray

Warnings

For external use only

Do not use

in or near the eyes

over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

When using this product

do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

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

Antiseptic Spray

Directions

clean the affected area

spray a small amount of this product on the area 1 to 3 times daily

may be covered with a sterile bandage

if bandaged, let dry first

Antiseptic Spray

Other information

shake well

store at room temperature 15

C (59

Antiseptic Spray

Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene

glycol, propylparaben, trolamine, water

Antiseptic Spray

Questions

1-800-430-5490

Eyesaline

Principal Display Panel

Povidone Iodine Swab

Principal Display Panel

Alcohol Wipe

Principal Display Panel

Neomycin

Principal Display Panel

Antiseptic Spray

Principal Display Panel

4316 Kit Label

SF00004530

4316 Kit Contnets

SF00004530

2 BLUE DETEC FNGERTP 8 WVN 25/B

1 BLUE DETEC KNUCKLE WVN 40/BX

2 BLUE DETEC PLASTIC 1X3 100/B

1 NEOMYCIN ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 ALCOHOL PREP PADS 10P

4 PVP IODINE WIPES 10 PER

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 TWEEZER PLASTICS 4"

1 ADH BAND PLSTC EX-LG 25 PER

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 FIRST AID GUIDE ASHI

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 3"

1 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

5 PR LRG NITRILE GLVES ZIP BAG

1 KIT ST MED FA CABINET-SP SHELF

1 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

4316 FIRST AID KIT

4 316 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4316

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4316 -0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

118 mL

Pa rt 2

20 POUCH

8 mL

Pa rt 3

40 POUCH

12 mL

Pa rt 4

1 BOTTLE, SPRAY

59 mL

Pa rt 5

10 PACKET

9 g

Part 1 of 5

EYESALINE EMERGENCY EYEWASH

purified water liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 10 0

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 2

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

12/18 /20 18

Part 2 of 5

ALCOHOL WIPE

isopropyl alcohol swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 143

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -

UNII:ND2M416 30 2)

ISOPROPYL

ALCOHOL

0 .7 mL in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 143-0 4

0 .4 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 9 /18 /20 18

Part 3 of 5

PVP IODINE WIPE

povidone-iodine 10% swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 121

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4)

IODINE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 121-0 0

0 .3 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /18 /20 18

Part 4 of 5

ANTISEPTIC

benzalkonium chloride spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 40 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

O CTO XYNO L 9 (UNII: 7JPC6 Y25QS)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 49 8 -0 40 2-

59 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /18 /20 18

Part 5 of 5

NEOMYCIN

antibiotic ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 730

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN SULFATE

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 730 -0 1

0 .9 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 3/31/20 10

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

10 /18 /20 18

Labeler -

Honeywell Safety Products USA, INC (079287321)

Honeywell Safety Products USA, INC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, INC

0 79 28 7321

pa c k(0 49 8 -4316 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Water-Jel Techno lo gies

15552258 9

manufacture(0 49 8 -0 730 , 0 49 8 -0 40 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc.

16 7518 6 17

ma nufa c ture (0 49 8 -0 10 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Changzho u Mao kang Medical

4213170 73

ma nufa c ture (0 49 8 -0 143)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sio n Bio text Medical

53277519 4

ma nufa c ture (0 49 8 -0 121)

Revised: 5/2019

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