4166 FIRST AID KIT- 4166 first aid

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

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
Honeywell Safety Products USA, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
External analgesic - temporarily relieves pain due to minor burns First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in: - minor cuts - scrapes - burns First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water - 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 Antiseptic - for handwashing to decrease bacteria on skin whenever soap and water is not readily available 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, 0498-0143-04, 0498-0203-00, 0498-0501-00, 0498-0733-00, 0498-0750-35, 0498-4166-01

4166 FIRST AID KIT- 4166 first aid

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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4166 First Aid Kit (Triple, EW, Burn Jel, BZK wipe, alcohol wipe, sting relief, PAWS- 6836JEA)

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

Triple

Active ingredient

Bacitracin zinc 400 units

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Polymyxin B sulfate 5000 units

Triple

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple

Uses

first aid to help prevent infection in:

minor cuts

scrapes

burns

Triple

Warnings

For external use only

Allergy alert: do not use if you are allergic to any of the ingredients

Do not use

in the eyes

over large areas of the body

Ask a doctor before use if you have

a deep or puncture wounds

animal bites

serious burns

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 the reach of children

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

Triple

Directions

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

Triple

Other information

store at 15

to 25

C (59

to 77

tamper evident sealed packets

do not use if packet is torn or opened

Triple

Inactive ingredient

petrolatum

Triple

Questions?

1-800-430-5490

BZK Wipe

Active ingredient

Benzalkonium chloride 0.13% w/v

BZK Wipe

Purpose

First aid antiseptic

BzK Wipe

Uses

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

BZK Wipe

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 Wipe

Directions

tear open packet and use as a washcloth

BZK Wipe

Other information

store at room temperature 15

to 30

C (59

- 86

do not reuse towelette

BZK Wipe

Inactive ingredient

water

BZK Wipe

Questions

1-800-430-5490

Sting Relief

Active ingredient (in each wipe)

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief

Purposse

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

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

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

PAWS

Active ingredient

Ethyl alcohol 66.5%

PAWS

Purpose

Antiseptic

PAWS

Uses

for handwashing to decrease bacteria on skin whenever soap and water is not readily available

PAWS

Warnings

For external use only

Flammable: keep away from fire or flame

Do not use

in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develop and persists for more than 72 hours

Keep out of reach of children

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

PAWS

Directions

wet hands and wrists thoroughly for 15 seconds and allow to air dry

always reseal after use

children under 6 years of age should be supervised when using this product

PAWS

Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Paws

Questions

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 burns

Alcohol

Warnings

For external use only

Flammable, keep away from fire and flame

Do not use

in or near 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 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

Alcohol

Questions

1-800-430-5490

4166

6836JEA Kit Contents

1 FINGERTIP 8 WOVEN 25/BOX

1 1X3 WOVEN SING 50/BOX

1 SWIFT KNUCKLE 40/BX

1 TRIPLE ANTIBIOTIC 10 PER

1 INSTANT COLD PACK 4" X 6"

1 BURN JEL 1/8 OZ, 6 PER

1 ALCOHOL PREP PADS 10P

1 ANTIMCRBL ANTSPTC TWLETTS

1 ADHESIVE TAPE W/P 1" X 10YDS

1 FIRST AID GUIDE ASHI

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 BLOODSTOPPER

1 GZE PADS STERILE 3"X 3" 10'S

1 CO-FLEX BANDAGE 2"X 5YDS TAN

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

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"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 36 UN WHT 01 HOR SHELF

1 TRI BNDG NON WOVEN 40"X40"X56"

1 STING RELIEF SWAB 10

1 CPR MSK,WPS,GLVS 1

Burn Jel label

Triple Antibiotic label

Antiseptic Towelette label

Sting Relief label

Eyewas h

PAWS label

Alcohol

Principal Display Panel

4166 kit label

6836JEA

4166 FIRST AID KIT

4 166 first aid kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -416 6

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -416 6 -0 1

1 in 1 KIT

0 9 /13/20 18

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

6 PACKET

21 g

Pa rt 2

2 PACKET

0 .0 0 38 L

Pa rt 3

1 BOTTLE

118 mL

Pa rt 4

10 PACKET

9 g

Pa rt 5

1 PACKET

1.4 mL

Pa rt 6

10 POUCH

4 mL

Pa rt 7

10 POUCH

4 mL

Part 1 of 7

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

TEA TREE O IL (UNII: VIF56 5UC2G)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

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

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 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 2 of 7

PAWS

ethyl alcohol liquid

Product Information

Ite m Code (Source )

NDC:0 49 8 -3111

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

6 6 5 mL in 1 L

Inactive Ingredients

Ingredient Name

Stre ng th

TRO LAMINE (UNII: 9 O3K9 3S3TK)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

0 .0 0 19 L 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 3 of 7

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, DIBASIC (UNII: GR6 8 6 LBA74)

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

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

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 4 of 7

TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 750

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [iU] in 1 g

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [iU] in 1 g

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

NEOMYCIN

3.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 750 -35

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 9 /19 /20 18

Part 5 of 7

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

12/22/20 17

Part 6 of 7

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 7 of 7

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

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

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 /13/20 18

Labeler -

Honeywell Safety Products USA, Inc. (079287321)

Registrant -

Honeywell Safety Products USA, Inc. (079287321)

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 -416 6 )

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 20 3, 0 49 8 -0 750 )

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 10 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc.

16 7518 6 17

manufacture(0 49 8 -0 50 1, 0 49 8 -0 143)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Honeywell Safety Products USA, Inc.

Changzho u Mao kang Medical

4213170 73

manufacture(0 49 8 -0 733, 0 49 8 -3111)

Revised: 4/2019

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