4121 FIRST AID KIT- 4121 fist 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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4121 (Eyewash, First Aid Pack 25 Standard- 680025SM, SF00004232, SF00004024, SF00001641, 680025FUN, 65025041900, 68U70GALLSANSI)

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

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 Safety Products USA, Inc. Smithfield, RI 02917

Antiseptic Towelette
Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Towelette
Purpose

First aid antiseptic

Antiseptic Towelette
Uses

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

Antiseptic Towelette
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

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.

Antiseptic Towelette
Directions

tear open packet and use as a washcloth

Antiseptic Towelette
Other information

store at room temperature 15 o to 30 oC (59 o - 86 oF)
do not reuse towelette

Antiseptic Towelette
Inactive ingredient

water

Antiseptic Towelette
Questions

1-800-430-5490

First Aid Burn Cream
Active ingredients

Benzalkonium chloride 0.13%

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
lin large areas of the body, particularly over raw surfaces or blistered areas
for more than 10 days

Keep out of reach of children

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

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

Ammonia Inhalent
Active ingredient (in each ampule)

Ammonia 15%

Ammonia
Purpose

Respiratory stimulant

Ammonia
Uses

to prevent or treat fainting

Ammonia
Warnings

For external use only

Do not use

if you have breathing problems such as asthma or emphysema

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

condition persists

Ammonia
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
Other information

store at room temperature away from light

Ammonia
Inactive ingredients

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

Ammonia
Questions or Comments

1-800-430-5490

4121
680025SM Kit Contents

1 3/4X3 PLAS SING 50/BOX
1 SWIFT WOVEN ASSORTED 20/BX
1 GAUZE BANDAGE, 4" X 6 YD
1 INSTANT COLD PACK 4" X 6"
1 ADHES TAPE W/P 1"X 2 1/2 YD
1 GAUZE CLEAN-WRAP BDGE N/S 2"
1 ABD COMBINE PAD 5" X 9"
1 1 OZ.EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 KIT TWEEZER 3 1/2" SLANTED
1 # 25 EMPTY NO LOGO BLANK
1 F. A. INST CHART SM (INDIVIDUAL LBL)
1 FIRST AID PACK FOR 25 STANDARD
1 TRI BNDG NON WOVEN 40"X40"X56"

Principal Display Panel
Eyesaline

Eyesaline

Principal Display Panel
Antiseptic Towelette

Antiseptic Wipe 1

Principal Display Panel
First Aid Burn Cream

First Aid Burn Cream

Principal Display Panel
Ammonia Inhalent

Ammonia Inhalent 1

4121 Kit Label
680025M Principal Display Panel

4121 label

4121 FIRST AID KIT
4121 fist aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4121

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4121-01	1 in 1 KIT	01/24/2019	10/18/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	30 mL
Part 2	6 PACKET	8.4 mL
Part 3	2 AMPULE	0.6 mL
Part 4	6 PACKET	5.4 g

Part 1 of 4

EYESALINE EMERGENCY EYEWASH
purified water liquid

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0100-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Part 2 of 4

ANTISEPTIC TOWELETTE
benzalkonium chloride liquid

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

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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/21/2017

Part 3 of 4

AMMONIA INHALENT
ammonia inhalent inhalant

Product Information
Item Code (Source)	NDC:0498-3334
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	0.045 g in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-3334-00	0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/18/2018

Part 4 of 4

FIRST AID BURN
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:0498-0903
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CETYL ALCOHOL (UNII: 936JST6JCN)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/24/2019	10/18/2019

Labeler - Honeywell Safety Products USA, Inc. (079287321)

Name	Address	ID/FEI	Business Operations
Establishment
James Alexander		040756421	manufacture(0498-3334)

Name	Address	ID/FEI	Business Operations
Establishment
Honeywell Safety Products USA, Inc.		079287321	pack(0498-4121)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(0498-0903)

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

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

Revised: 10/2019

Document Id: 9538efc5-9b34-71b4-e053-2a95a90adda5

Set id: 802aa429-668b-7cb5-e053-2a91aa0acace

Version: 2

Effective Time: 20191018

Honeywell Safety Products USA, Inc.

4121 (Eyewash, First Aid Pack 25 Standard- 680025SM, SF00004232, SF00004024, SF00001641, 680025FUN, 65025041900, 68U70GALLSANSI)

Eyesaline Active ingredient

Eyesaline Purpose

Eyesaline Uses

Eyesaline Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children

Eyesaline Directions

Eyesaline Inactive ingredients

Eyesaline Questions

Antiseptic Towelette Active ingredient

Antiseptic Towelette Purpose

Antiseptic Towelette Uses

Antiseptic Towelette Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children

Antiseptic Towelette Directions

Antiseptic Towelette Other information

Antiseptic Towelette Inactive ingredient

Antiseptic Towelette Questions

First Aid Burn Cream Active ingredients

First Aid Burn Cream Purpose

First Aid Burn Cream Uses

First Aid Burn Cream Warnings

Do not use

Keep out of reach of children

Ask a doctor before use if you have

Stop use and ask a doctor if

First Aid Burn Cream Directions

First Aid Burn Cream Other information

First Aid Burn cream Inactive ingredients

First Aid Burn cream Questions

Ammonia Inhalent Active ingredient (in each ampule)

Ammonia Purpose

Ammonia Uses

Ammonia Warnings

Do not use

Keep out of reach of children

Stop use and ask a doctor if

Ammonia Directions

Ammonia Other information

Ammonia Inactive ingredients

Ammonia Questions or Comments

4121 680025SM Kit Contents

Principal Display Panel Eyesaline

Principal Display Panel Antiseptic Towelette

Principal Display Panel First Aid Burn Cream

Principal Display Panel Ammonia Inhalent

4121 Kit Label 680025M Principal Display Panel

Eyesaline
Active ingredient

Eyesaline
Purpose

Eyesaline
Uses

Eyesaline
Warnings

Eyesaline
Directions

Eyesaline
Inactive ingredients

Eyesaline
Questions

Antiseptic Towelette
Active ingredient

Antiseptic Towelette
Purpose

Antiseptic Towelette
Uses

Antiseptic Towelette
Warnings

Antiseptic Towelette
Directions

Antiseptic Towelette
Other information

Antiseptic Towelette
Inactive ingredient

Antiseptic Towelette
Questions

First Aid Burn Cream
Active ingredients

First Aid Burn Cream
Purpose

First Aid Burn Cream
Uses

First Aid Burn Cream
Warnings

First Aid Burn Cream
Directions

First Aid Burn Cream
Other information

First Aid Burn cream
Inactive ingredients

First Aid Burn cream
Questions

Ammonia Inhalent
Active ingredient (in each ampule)

Ammonia
Purpose

Ammonia
Uses

Ammonia
Warnings

Ammonia
Directions

Ammonia
Other information

Ammonia
Inactive ingredients

Ammonia
Questions or Comments

4121
680025SM Kit Contents

Principal Display Panel
Eyesaline

Principal Display Panel
Antiseptic Towelette

Principal Display Panel
First Aid Burn Cream

Principal Display Panel
Ammonia Inhalent

4121 Kit Label
680025M Principal Display Panel