4346 First Aid Kit by Honeywell Safety Products USA, INC 4346 FIRST AID KIT kit

4346 First Aid Kit by

Drug Labeling and Warnings

4346 First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Triple Active ingredients

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 0 to 25 0 C (59 0 to 77 0 F)
• tamper evident sealed packets
• do not use if packet is torn or opened

Triple Inactive ingredient

petrolatum

Miralac Active ingredient (in each chewable tablet)

Miralac Purpose

Antacid

Miralac Uses

for the relief of

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms

Warnings

Ask a doctor before use if you have

• kidney stones
• calcium-restricted diet

Ask a doctor before use if you are

• presently taking a prescription drug. Antacids may interfere with certain prescription drugs

When using this product

• do not take more than 12 tablets in a 24- hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Keep out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Miralac Directions

• chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.

Miralac Other information

• each tablet contains: calcium 170 mg
• sucrose free
• lactose free
• store at room temperature
• TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Miralac Inactive ingredients

magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

Miralac 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 0 to 30 0 C (5 0 - 86 0 F)
• do not reuse towelette

BZK Inactiave ingredient

water

BzK Questions

1-800-430-5490

Questions or Comments?

1-800-430-5490

Pain Stopper Active ingredient (in each tablet)

Acetaminophen 110mg

Aspirin 162mg (NSAID)*

Caffeine 32.4mg

Salicylamide 152mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Stopper Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Diuretic

Pain reliever/fever reducer

Pain Stopper Uses

for the temporary relief of minor aches and pains due to:

common cold

headache

muscular aches

premenstrual and menstrual cramps

Pain Stopper 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 12 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Stop using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pin that does not get better
• if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.

If pregnant or breast-feeding

• ask a healthcare professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during pregnancy.

KEEP OUT OF REACH OF CHILDREN.

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Pain Stopper Directions

• adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
• do not take more than 12 tablets in 24 hours
• children under 12 years: consult a doctor

Pain Stopper Other information

• store at a controlled room temperature 15 0 -30 0 C (59 0 -86 0 F)
• TAMPER EVIDENT-DO NOT USE IF OPEN OR TORN

Pain Stopper Inactive ingredients

FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,

Pain Stopper Questions or Comments?

1-800-430-5490

Burn relief WJ Active ingredient

Lidocaine HCl 2%

Burn Relief WJ Purpose

External analgesic

Burn Relief WJ Uses

• temporarily relieves pain due to minor burns

Burn Relief WJ Warnings

For external use only

Do not use

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

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• condition clears up and occurs again within a few days

Keep out of the reach of children

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

Burn Relief WJ 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

Burn Relief WJ Other information

• store at room temperature

Burn Relief WJ Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Burn Relief WJ Questions or Comments?

1-800-430-5490

4346 Z68140GRR KIT CONTENTS

1 1X3 PLASTIC 100/BOX

1 WOVEN 7/8 X 3 50/BOX

1 SWIFT KNUCKLE 40/BX

1 SWIFT FINGERTIP 8 50/BOX

2 TRIPLE ANTIBIOTIC 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

1 INSTANT COLD PACK 4" X 6"

1 ADHESIVE TAPE W/P 1/2"X 5 YD

1 TWEEZER PLASTICS 4"

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

2 ANTISEPTIC WIPES BZK CHL 20'S

1 PAIN STOPPERS IND PK 2ENV 100

1 MIRALAC TABS IND PK 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 F A KIT EMPTY BLANK 140

1 POCKET INSERT RED #140 KIT 2R

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

1 TRI BNDG NON WOVEN 40"X40"X56"

Eyewash Principal Display Panel

Triple Principal Display Panel

Miralac Principal Display Panel

BZK Principal Display Panel

Pain Stopper Principal Display Panel

Burn Relieff WJ Principal Display Panel

4346 Kit Label Z68140GRR

INGREDIENTS AND APPEARANCE

4346 FIRST AID KIT 
4346 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4346

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4346-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	59 mL
Part 3	20 PACKET	18 g
Part 4	50 PACKET	100
Part 5	40 PACKET	56 mL
Part 6	50 PACKET	100

Part 1 of 6

EYESALINE EMERGENCY EYEWASH 
purified water liquid

Product Information
Item Code (Source)	NDC: 0498-0100
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.6 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0100-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/18/2018

Part 2 of 6

BURN RELIEF 
lidocaine hydrochloride spray

Product Information
Item Code (Source)	NDC: 0498-0221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	24.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
HYPROMELLOSES (UNII: 3NXW29V3WO)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0221-59	59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/18/2018

Part 3 of 6

TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Item Code (Source)	NDC: 0498-0750
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0750-35	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	09/19/2018

Part 4 of 6

MIRALAC 
calcium carbonate tablet

Product Information
Item Code (Source)	NDC: 0498-0303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	11mm
Flavor	MINT	Imprint Code	FR8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/22/2012

Part 5 of 6

ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC: 0498-0501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0501-00	1.4 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/22/2017

Part 6 of 6

PAIN STOPPERS 
acetaminophen, caffeine, aspirin, salicylamide tablet

Product Information
Item Code (Source)	NDC: 0498-2422
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange (BRIGHT ORANGE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2422-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2018

Labeler - Honeywell Safety Products USA, INC (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, INC		079287321	pack(0498-4346)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(0498-2422, 0498-0303)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(0498-0750, 0498-0221)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc.		167518617	manufacture(0498-0100)

Establishment
Name	Address	ID/FEI	Business Operations
Changzhou Maokang Medical		421317073	manufacture(0498-0501)