4129 FIRST AID KIT kit

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

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Active ingredient:
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
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 First aid antiseptic - first aid antiseptic to help prevent infection in minor cuts, scrapes and burns Antiseptic Topical pain relief - prevent infection in minor scrapes, and temporary relief of itching of insect bites First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burnsv Anti-itch cream - for the temporary relief of itching associated with minor skin irritations and rashes First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and wate
Authorization status:
unapproved drug other
Authorization number:
0498-0011-77, 0498-0121-00, 0498-0143-04, 0498-0501-00, 0498-0733-00, 0498-0800-34, 0498-3334-00, 0498-4129-01

4129 FIRST AID KIT- 4129 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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4129 First Aid Kit (alcohol wipes, HC cr, BZK wipe, Pyrocaine Sp, PVP wipe, amm. Inh, Sting

relief- SF00004226)

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

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

Sting Relief

Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief

Purpose

Antiseptic

Topical pain relief

Sting Relef

Uses

prevent infection in minor scrapes, and temporary relief of itching of insect bites

Sting Relief

Warnings

For external use only

Flammable, keep away from open fire or flame

Do not use

over large areas of the body

in eyes

over raw or blistered areas

Stop use and ask a doctor

if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Sting Relief

Directions

adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily.

children under 2 years of age: consult a doctor.

Sting Relief

Inactive ingredients

benzalkonium chloride, menthol, and purified water

Sting Relief

Questions or Comments?

1-800-430-5490

alcohol

Active ingredient

Isopropyl alcohol 70%

Alcohol

Purpose

First aid antiseptic

Alcohol

Uses

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

Alcohol

Warnings

For external use only

Flammable, keep away from fire and flame

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 1 week unless directed by a doctor

Stop use and consult a doctor if

condition persists or gets worse

Keep out of the reach of children

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

Alcohol

Directions

clean the affected area

may be covered with a sterile bandage

apply wipe to affeted are 1 to 3 times daily

discard wipe after single use

Alcohol

Other information

store at room temperature 15

to 25

C (59

to 77

do not use if packet is torn or opened

Alcohol

Inactive ingredient

water

Alcojol

Questions

1-800-430-5490

Hydrocortisone

Active ingredient (in each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Hydrocortisone

Purpose

Anti-itch cream

Hydrocortisone

Uses

for the temporary relief of itching associated with minor skin irritations and rashes

Hydrocortisone

Warnings

For external use only

Ask a doctor before use

if you are using any other hydrocortisone product

When using the product

avoid contact with eyes

do not begin use of any other hydrocortisone product unless you have consulted a doctor

do not use for the treatment of diaper rash

Stop use and ask a doctor if

condition worsens

condition persists 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.

Hydrocortisone

Directions

adults and children 2 years and older:

clean the affected area

apply to the area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Hydrocortisone

Other information

store at room temperature (do not freeze)

Hydrocortisone

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate,

methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water,

stearic acid, trolamine

Hydrocortisone

Questions or comments?

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

4129

SF00004226 Kit Contents

1 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 TRIANGULAR BDG, NON-STERILE

1 INSTANT COLD PACK 4" X 6"

1 ALCOHOL PREP PADS 10P

1 HYDROCORTISON,1.O%,1/32 OZ,10P

1 RESPONSE KIT BLOODBORNE PATHOG

1 SCISSOR BDGE 4" RED PLS HDL

1 BANDAGE COMP 2" W/TELFA PAD 4

1 BANDAGE COMP 4" W/TELFA PAD 1

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 PR LRG NITRILE GLVES ZIP BAG

1 1" X 3" PLASTIC BANDS 16/BAG

1 KIT STL 24 UN WHITE 01

1 PVP IODINE SWABS 10

1 STING Relief SWAB 10

1 PYRO-CAINE AERO 2/BX

1 RED BIO BAGS 2/BX

1 FACE MASK/EYE SHIELD

1 LIQD TRTMNT SYS 1 EA

1 DISP. TOWEL/WIPES 2EA

1 IMPERVIOUS GOWN 1 EA

Ammonia

Principal Display Panel

Pyrocaine

Principal Display Panel

PVP

Principal Display Panel

Sting Relief

Principal Display Panel

Alcohol

Principal Display Panel

Hydrocortisone

Principal Display Panel

BZK

Principal Display Panel

4129 Kit Label

SF00004226

4129 FIRST AID KIT

4 129 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4129

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4129 -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

10 PACKET

9 g

Pa rt 2

10 AMPULE

3 mL

Pa rt 3

2 CAN

28 .4 g

Pa rt 4

10 POUCH

4 mL

Pa rt 5

10 POUCH

3 mL

Pa rt 6

4 PACKET

5.6 mL

Pa rt 7

10 POUCH

4 mL

Pa rt 8

10 PACKET

9 g

Part 1 of 8

HYDROCORTISONE

anti-itch cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

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 no t final

pa rt348

0 3/0 6 /20 13

Part 2 of 8

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 8

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 8

STING RELIEF PAD

ethyl alcohol, lidocaine swab

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 733

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ALCOHOL

0 .5 mL

in 1 mL

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

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE HYDROCHLORIDE

ANHYDROUS

20 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

MENTHO L (UNII: L7T10 EIP3A)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 733-0 0

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 rt348

12/23/20 17

Part 5 of 8

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 6 of 8

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

Part 7 of 8

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 8 of 8

HYDROCORTISONE

anti-itch cream ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 8 0 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE ACETATE (UNII: 3X79 31PO74) (HYDROCORTISONE -

UNII:WI4X0 X7BPJ)

HYDROCORTISONE

ACETATE

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 8 0 0 -34

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 no t final

pa rt348

0 3/0 6 /20 13

10 /15/20 19

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)

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 -4129 )

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

manufacture(0 49 8 -0 8 0 0 , 0 49 8 -0 8 0 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Chanzho u Mao kang Medical

4213170 73

manufacture(0 49 8 -0 143, 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)

Honeywell Safety Products USA, INC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Safetec o f America Inc

8 749 6 526 2

ma nufa c ture (0 49 8 -0 733)

Revised: 10/2019

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