4133 FIRST AID KIT- 4133 first aid kit

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

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Topical pain relief - prevent infection in minor scrapes, and temporary relief of itching of insect bites Eyewash - for flushing the eye to remove loose foreign material, air pollutants or chlorinated water Respiratory stimulant - to prevent or tret fainting External analgesic - temporarily relieves pain due to minor burns 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
Authorization status:
unapproved drug other
Authorization number:
0498-0100-01, 0498-0121-00, 0498-0143-04, 0498-0203-00, 0498-3334-00, 0498-4133-01

4133 FIRST AID KIT- 4133 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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4133 First Aid Kit (ammonia inh, EW, Burn Jel, PVP wipes, alcohol wipes, sting relief-

SF00004171)

Sting Relief

Active ingredient

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief

Purpose

Antiseptic

Topical pain relief

Sting Relief

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

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

Ammonia Inhalent

Active ingredient

Ammonia 15%

Ammonia Inhalent

Purpose

Respiratory stimulant

Ammonia Inhalent

Uses

to prevent or tret fainting

Ammonia Inhalent

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 Inhalent

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 Inhalent

Other information

store at room temperature away from light

Ammonia Inhalent

Other information

store at room temperature away from light

Ammonia Inhalent

Inactive ingredients

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

Ammonia Inhalent

Questions or Comments

1-800-430-5490

Burn Jel

Active ingredient

Lidocaine HCl 2.0%

Burn Jel

Purpose

External analgesic

Burn Jel

Uses

temporarily relieves pain due to minor burns

Burn Jel

Warnings

For external use only

Do not use

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

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

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

4133

SF00004171 Kit Contents

1 KNUCKLE BAND 8 PER

1 AMMONIA INHALANTS 10 PER

1 GAUZE BANDAGE, 4" X 6 YD

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 3" X 3", 4 PER

1 ADHESIVE TPE 1"X2-1/2 YD 2 PER

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

1 1 OZ EYE WASH W/PADS & STRIPS

1 BURN JEL 1/8 OZ, 6 PER

1 PVP IODINE WIPES 10 PER

1 STING RELIEF WIPES 10 PER BOX

1 MICROSHIELD W/VNL GLV/ALCL

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 16 UN (VERTICAL)

1 LABL INSTR FA REV A

Sting Relief

Principal Display Panel

Eyesaline

Principal Display Panel

Ammonia inhalent

Principal Display Panel

Burn Jel

Principal Display Panel

Povidone Iodine Swab

Principal Display Panel

Alcohol Wipe

Principal Display Panel

4133 Kit Label

SF00004171

4133 FIRST AID KIT

4 133 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4133

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4133-0 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 POUCH

4 mL

Pa rt 2

1 BOTTLE

30 mL

Pa rt 3

10 AMPULE

3 mL

Pa rt 4

4 POUCH

1.6 mL

Pa rt 5

10 POUCH

3 mL

Pa rt 6

6 PACKET

21 g

Part 1 of 6

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

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

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

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

MENTHO L (UNII: L7T10 EIP3A)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

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 2 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 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 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 3 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 4 of 6

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 5 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 6 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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

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

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

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

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

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

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

TEA TREE O IL (UNII: VIF56 5UC2G)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

Honeywell Safety Products USA, INC

OTC mo no graph no t final

pa rt348

0 9 /19 /20 18

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 -4133)

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 -0 143)

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)

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: 5/2019

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