4345 FIRST AID KIT- 4345 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 Respiratory stimulant - to prevent or treat fainting Topical anesthetic Topical antiseptic For the temporary relief of pain and itching, and to help protect against skin infection in: - minor burns - minor skin irritations - minor cuts and scrapes - insect bites - sunburns - in or near the eyes or over large portions of the body - in case of deep or puncture wounds or on: - raw surfaces - blistered areas - animal bites - serious burns - If swallowed, get medical help or contact a Poison Control Center right away External analgesic - temporarily relieves pain due to minor burns - on large areas of the body, particularly over raw surfaces or blistered areas First aid antiseptic - first aid antiseptic to help prevent infection in minor cuts, scrapes and burns First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water
Authorization status:
unapproved drug other
Authorization number:
0498-0011-77, 0498-0100-01, 0498-0121-00, 0498-0203-00, 0498-0501-00, 0498-3334-00, 0498-4345-01

4345 FIRST AID KIT- 4345 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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4345 First Aid Kit (Pyrocaine Sp, EW, Burn Jel, PVP wipe, BZK wipes, amm. Inh- Z019852)

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

Ammonia

Active ingredient

Ammonia 15%

Ammonia

Purpose

Respiratory stimulant

Ammonia

Uses

to prevent or treat fainting

Ammonia

Warnings

For external use only

Do not use

if you have breathing problems such as asthma or emphysema

Stop use and ask a doctor if

condition persists

Keep out of reach of children

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

Ammonia

Directions

hold inhalant away from face and crush ampoule between thumb and forefinger at position indicated

on sleeve.

hold near nostrils for inhalation of volatile vapor

Ammonia

Other information

store at room temperature away from light

Ammonia

Inactive ingredient

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Ammonia

Questions or Comments?

1-800-430-5490

Pyrocaine

Active ingredient

Benzocaine 20%

Benzethonium chloride 0.2%

Pyrocaine

Purpose

Topical anesthetic

Topical antiseptic

Pyrocaine

Uses

For the temporary relief of pain and itching, and to help protect against skin infection in:

minor burns

minor skin irritations

minor cuts and scrapes

insect bites

sunburns

Do not use

in or near the eyes or over large portions of the body

in case of deep or puncture wounds or on:

raw surfaces

blistered areas

animal bites

serious burns

Keep out of reach of children

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

Pyrocaine

Warnings

For external use only

Flammable

keep away from fire or flame

contents under pressure

do not puncture, incinerate or expose container to temperatures above 120 o F

Stop use and ask a doctor if

If condition persists or worsens, or if symptoms persist for more than 7 days or clear up and occur

again within a few days

Pyrocaine

Directions

clean the affected area

shake can well before using

hold can 6 to 12 inches away from the affected area and spray liberally

apply to affected area not more than 3 times daily

for adult institutional use only

not intended for use on children

Pyrocaine

Other information

avoid inhaling

use only as directed

intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Pyrocaine

Inactive ingredients

butane,dipropylene glycol, isobutane, propane

Burn Jel

Active ingredient

Lidocaine HCL 2.0%

Burn Jel

Purpose

External analgesic

Burn Jel

USes

temporarily relieves pain due to minor burns

Do not use

on large areas of the body, particularly over raw surfaces or blistered areas

Burn Jel

Warnings

For external use only

When using this product

avoid contact with eyes

Stop use and ask a doctor if

the condition gets worse

symptoms persist for more than 7 days

condition clears up and recurs within a few days

Keep out of reach of children

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

Burn Jel

Directions

adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

children under 2 years of age: ask a doctor

you may report a serious reaction to this product to 800-430-5490

Burn Jel

Other information

store at room temperature

do not use if opened or torn

Burn Jel

Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil,

methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel

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 help or 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

discard wipe after single use

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

BZK

Active ingredient

Benzalkonium chloride 0.13% w/v

BZK

Purpose

First aid antiseptic

BZK

Uses

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

BZK

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

Directions

tear open packet and use as a washcloth

BZK

Other information

store at room temperature 15

to 30

C (59

- 86

do not reuse towelette

BZK

Inactive ingredient

water

BZK

Questions

1-800-430-5490

4345

Z019852 Kit Contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 TRIANGULAR BDG, NON-STERILE

2 INSTANT COLD PACK 4" X 6"

1 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 3" OFFSET, 2 PER

1 BANDAGE COMP, 4" OFFSET, 1 PER

2 BURN JEL 1/8 OZ, 6 PER

1 WATER JEL DRESSING 4" X 4"

1 PVP IODINE WIPES 10 PER

1 ANTIMCRBL ANTSPTC TWLETTS

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 LBL CONTS 8"X8",CUSTOM ID B

1 KIT PP 24 UNIT FA

8 BLUE DETECTABLE KNUCKLE

1 ADHS TAPE .5"X2.5YD 2

1 PYRO-CAINE AERO 2/BX

1 SCISSOR & FORCEP 1 EA

2 BLUE 1"X3" BANDS 16'S

1 BLUE FINGERTIP "8" 8'S

Eyewash

Principal Display Panel

Ammonia

Principal Display Panel

Pyrocaine

Principal Display Panel

Burn Jel

Principal Display Panel

PVP

Principal Display Panel

BZK

Principal Display Panel

4345 Kit Label

Z019852

4345 FIRST AID KIT

4 34 5 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4345

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4345-0 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

30 mL

Pa rt 2

10 AMPULE

3 mL

Pa rt 3

2 CAN

28 .4 g

Pa rt 4

10 POUCH

3 mL

Pa rt 5

12 PACKET

42 g

Pa rt 6

1 PACKET

1.4 mL

Part 1 of 6

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

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 10 0 -0 1

30 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 6

AMMONIA INHALENT

ammonia inhalent inhalant

Product Information

Ite m Code (Source )

NDC:0 49 8 -3334

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AMMO NIA (UNII: 5138 Q19 F1X) (AMMONIA - UNII:5138 Q19 F1X)

AMMONIA

0 .0 45 g in 0 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -3334-0 0

0 .3 mL in 1 AMPULE; 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 3 of 6

PYROCAINE BURN

benzocaine, benzethonium chloride aerosol, spray

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 0 11

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 g in 10 0 g

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM -

UNII:1VU15B70 BP)

BENZETHONIUM

CHLORIDE

0 .2 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

1,1,3 -TRI( 3 -TERT-BUTYL-4 -HYDRO XY-6 -METHYLPHENYL) BUTANE (UNII: BF6 E9 O0 XJN)

ISO BUTANE (UNII: BXR49 TP6 11)

1,1,3 -TRIS( 2 -CHLO RO ETHO XY) PRO PANE (UNII: 4FEX9 N8 8 8 E)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 0 11-77

14.2 g in 1 CAN; 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 rt348

0 1/0 1/20 18

Part 4 of 6

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 5 of 6

BURN JEL

gel for burns gel

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 20 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER HO MO PO LYMER TYPE B ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: HHT0 1ZNK31)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

GLYCERIN (UNII: PDC6 A3C0 OX)

TEA TREE O IL (UNII: VIF56 5UC2G)

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 20 3-0 0

3.5 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 no t final

pa rt348

0 9 /19 /20 18

Part 6 of 6

ANTISEPTIC TOWELETTE

benzalkonium chloride liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 50 1

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

1.3 mg

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 50 1-0 0

1.4 mL 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 no t final

pa rt333E

12/21/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Honeywell Safety Products USA, INC

unappro ved drug o ther

10 /18 /20 18

Labeler -

Honeywell Safety Products USA, INC (079287321)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

James Alexander

0 40 756 421

ma nufa c ture (0 49 8 -3334)

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 -4345)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dixo n Investments

1153158 22

ma nufa c ture (0 49 8 -0 0 11)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Water-Jel Techno lo gies

15552258 9

ma nufa c ture (0 49 8 -0 20 3)

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 50 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sio n Medical Bio text

53277519 4

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

Revised: 5/2019

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