4312 First Aid Kit by Honeywell Safety Products USA, INC 4312 FIRST AID KIT kit

4312 First Aid Kit by

Drug Labeling and Warnings

4312 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]

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

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 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

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

Stop use and consult a doctor if

• condition persists or gets worse

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

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

Alcohol Inactive ingredient

water

Alcohol Questions

1-800-430-5490

4312 SF00004471 Kit Contents

1 TRIANGULAR BDG, NON-STERILE

1 INSTANT COLD PACK 4" X 6"

1 BUFFERED EYE WASH 1 OZ BTL

2 BANDAGE COMP, 4" OFFSET, 1 PER

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

1 FINGERTIP BANDAGE, 10 PER

1 ALCOHOL PREP PADS 10P

1 NITRILE GLOVES 2PR BBP

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

2 WATER JEL BURN DRESSING 4 X 16

1 KIT STL 16 UN (VERTICAL)

1 LABL INSTR FA REV A

4 GAUZE PADS 3"X3" 12PLY

1 STING Relief WIPES 10

Sting Relief Principal Display Panel

Eyewash Principal Display Panel

Alcohol Principal Display Panel

4312 Kit Label SF00004471

INGREDIENTS AND APPEARANCE

4312 FIRST AID KIT 
4312 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-4312

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-4312-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 POUCH	4 mL
Part 2	1 BOTTLE	30 mL
Part 3	10 POUCH	4 mL

Part 1 of 3

STING RELIEF PAD 
ethyl alcohol, lidocaine swab

Product Information
Item Code (Source)	NDC: 0498-0733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.5 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.4 mL in 1 POUCH; 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	12/23/2017

Part 2 of 3

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 CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0100-01	30 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	10/18/2018

Part 3 of 3

ALCOHOL WIPE 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 0498-0143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-0143-04	0.4 mL in 1 POUCH; 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	part333A	09/18/2018

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(0498-4312)

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(0498-0143)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America Inc		874965262	manufacture(0498-0733)