4250 FIRST AID KIT- 4250 first aid kit

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
Honeywell Safety Products USA, INC
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antiseptic External analgesic - prevent skin infection - for temporary relief of pain associated with minor burns First aid antibiotic First aid antibiotic First aid antibiotic first aid to help prevent infection in - minor cuts - scrapes - burns Pain reliever/fever reducer temporarily reduces fever and relieves minor aches and pains associated with: - a cold - headache - toothache - muscular aches - backache - minor pain of arthritis - premenstrual and menstrual periods First aid antiseptic Antiseptic cleansing of face, hands, and body without soap and water First aid antiseptic - first aid to help prevent infection in minor cuts, scrapes, and burns
Authorization status:
unapproved drug other
Authorization number:
0498-0114-01, 0498-0143-04, 0498-0501-00, 0498-0750-35, 0498-4250-01

4250 FIRST AID KIT- 4250 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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4250 First Aid Kit (BZK wipes, FABC, triple,alcohol wipe, ASA- 68P10SCHW)

First Aid Burn Cream

Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream

Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream

Uses

prevent skin infection

for temporary relief of pain associated with minor burns

First Aid Burn Cream

Warnings

For external use only

Do not use

in or near the eyes

if you are allergic to any of the ingredients

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

for more than 10 days

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

symptoms persist for more than 7 days or clear up and occurs again within a few days

First Aid Burn Cream

Directions

adults and children 2 years of age and older:

clean the affected area

apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected

area 1 to 3 times daily

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

First Aid Burn Cream

Other information

tamper evident sealed packets

do not use if packet is opened or torn

First Aid Burn Cream

Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate

SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine,

water

First Aid Burn Cream

Questions

1-800-430-5490

Triple

Active ingredient (each gram contains)

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

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

F) tamper evident sealed packets - do not use if packet is torn or

opened

Triple

Inactive ingredient

petrolatum

Triple

Questions

1-800-430-5490

Aspirin

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Aspirin

Purpose

Pain reliever/fever reducer

Aspirin

Uses

temporarily reduces fever and relieves minor aches and pains associated with:

a cold

headache

toothache

muscular aches

backache

minor pain of arthritis

premenstrual and menstrual periods

Aspirin

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this product. When using this product, if changes in behavior with nausea and

vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a

rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you:are:

age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,

or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems such as heartburn

you have high blood pressure, heart disease, liver cirrhosis or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present in the painful area

ringing in the ears or loss of hearing occurs

any new symptoms appear

If pregnant or breast-feeding,

If pregnant or breat-feeding, ask a health professional before use. It is especially important not to use

aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because

it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Aspirin

Directions

drink a full glass of water with each dose

adults and children 12 years of age and older: take 1 or 2 tablets every 4 hours while symptoms last,

not more than 12 tablets in 24 hours

children under 12 years of age: consult a doctor

Aspirin

Other information

store at room temperature 15° - 30°C (59° - 86°F)

TAMPER EVIDIENT PACKETS

DO NOT USE IF OPEN OR TORN

Aspirin

Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, microcrystalline cellulose*, mineral oil*,

polyethylene glycol*, povidone, propylene glycol, silicon dioxide, stearic acid*, titanium dioxide*

*may contain these ingredients

Aspirin

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

Keep out of reach of children

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

Stop use and ask a doctor if

irritation, redness or other symptoms develop

the condition persists or gets worse

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 ingredients

water

BZK

Questions

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 Wipes

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 Wipe

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 Wipe

Other information

store at room temperature 15

to 25

C (59

to 77

do not use if packet is torn or opened

Alcohol Wipe

Inactive ingredient

water

Alcohol Wipe

Questions

1-800-430-5490

4250

68P10SCHW Kit Contents

1 INSTANT COLD PACK 4" X 6"

1 ADH BDG,PLSTIC,3/4"X3",16 PER

1 TWEEZER PLASTICS 4"

1 FIRST AID GUIDE ASHI

1 TAPE ADHESIVE 1"X 5 YD PLSTC

1 GAUZE CLEAN-WRAP BDGE N/S 2"

1 GAUZE CLEAN-WRAP BDGE N/S 3"

1 ABD COMBINE PAD 5" X 9"

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

6 BZK ANTISEPTIC WIPE, BULK

2 PR LRG NITRILE GLVES ZIP BAG

6 FIRST AID CREAM 1.0GR PKT EACH

3 TRIPLE BIOTIC FOIL PACK EACH

6 WIPE ALCOHOL PREP IPA 70% (DUKAL)

1 KIT, PP 10 UNIT FA

1 TRI BNDG NON WOVEN 40"X40"X56"

4 GAUZE PADS 2"X2" 12PLY

1 EYE PADS STD OVAL STERILE

4 GAUZE PADS 3"X3" 12PLY

2 GAUZE PADS 4"X4" 12PLY

1 WOVEN FINGERTIP BANDAGE 2"

1 HEAVY FLEX LARGE PATCH 2" X 3"

3 ASPIRIN BULK 2/PK

First Aid Burn Cream

Principal Display Panel

Triple

Principal Display Panel

Aspirin

Principal Display Panel

BZK

Principal Display Panel

Alcohol Wipe

Principal Display Panel

4250 Kit Label

68FP10SCHW

4250 FIRST AID KIT

4 250 first aid kit kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -4250

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -4250 -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

6 PACKET

5.4 g

Pa rt 2

6 PACKET

8 .4 mL

Pa rt 3

3 PACKET

Pa rt 4

3 PACKET

2.7 g

Pa rt 5

6 POUCH

2.4 mL

Part 1 of 5

FIRST AID BURN

benzalkonium chloride, lidocaine hydrochloride cream

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 9 0 3

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 g

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

HYDROCHLORIDE

0 .5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

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

WATER (UNII: 0 59 QF0 KO0 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

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

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

TRO LAMINE (UNII: 9 O3K9 3S3TK)

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

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 rt333A

12/20 /20 17

Part 2 of 5

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

0 9 /18 /20 18

Part 3 of 5

ASPIRIN

aspirin tablet

Product Information

Ite m Code (Source )

NDC:0 49 8 -0 114

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

STARCH, CO RN (UNII: O8 232NY3SJ)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SE 2 2 0 8 ( 10 0 MPA.S) (UNII: B1QE5P712K)

MINERAL O IL (UNII: T5L8 T28 FGP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

FR21

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 49 8 -0 114-0 1

2 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 rt343

0 9 /18 /20 18

Part 4 of 5

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

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

BACITRACIN

40 0 [iU] in 1 g

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

POLYMYXIN B

50 0 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 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)

Honeywell Safety Products USA, INC

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

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

Ho neywell Safety Pro ducts USA, INC

0 79 28 7321

pa c k(0 49 8 -4250 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultra Seal Co rpo ratio n

0 8 57520 0 4

ma nufa c ture (0 49 8 -0 114)

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 9 0 3, 0 49 8 -0 750 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Changzho u Mao kang Medical

4213170 73

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

Revised: 5/2019

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