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

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%

Eyewassh
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.

Eyeash
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

Eyeash
Questions

Call 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
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 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

PVP
Active ingredient

Povidone-iodine 10% (equivalent to 1% titratable iodine)

PVP
Purpose

First aid antiseptic

PVP
Uses

first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

PVP
Warnings

For external use only.

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 or persists for more than 72 hours
irritation and redness develops

Keep out of reach of children.

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

PVP
Directions

clean the affected area
apply1 to 3 times daily
may be covered with a sterile bandage
if bandaged, let dry first
discard wipe after single use

PVP
Other information

do not use on individuals who are allergic or sensitive to iodine
store at controlled temperature 59-86ºF (15-30ºC)
do not use if pouch is open or torn

PVP

Inactive ingredients

nonoxynol 9, water

4311
SF00004446 Kit Contents

1 KNUCKLE BAND 8 PER

2 INSTANT COLD PACK 4" X 6"

1 BUFFERED EYE WASH 1 OZ BTL

1 BANDAGE COMP, 4" OFFSET, 1 PER

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

1 BURN JEL 1/8 OZ, 6 PER

1 ALCOHOL PREP PADS 10P

1 PVP IODINE WIPES 10 PER

1 STING RELIEF WIPES 10 PER BOX

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

1 POISON OAK/IVY CLEANSER 4 OZ

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

2 PR LRG NITRILE GLVES ZIP BAG

1 KIT STL 16 UN (HORIZONTAL)

Burn Jel
Principal Display Panel

Burn Jel

Sting Relief
Principal Display Panel

Sting Relief

Eyewash
Principal Display Panel

Eyesaline

Alcohol
Principal Display Panel

Alcohol Preps

PVP
Principal Display Panel

PVP Wipe

4311 Kit Label
SF00004446

4311 label

4311 FIRST AID KIT
4311 first aid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4311

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4311-01	1 in 1 KIT	09/13/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	6 PACKET	21 g
Part 2	1 BOTTLE	30 mL
Part 3	10 POUCH	4 mL
Part 4	10 POUCH	4 mL
Part 5	10 POUCH	3 mL

Part 1 of 5

BURN JEL
gel for burns gel

Product Information
Item Code (Source)	NDC:0498-0203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
TEA TREE OIL (UNII: VIF565UC2G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0203-00	3.5 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
unapproved drug other		09/19/2018

Part 2 of 5

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

#	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 Drug	M018	12/18/2018

Part 3 of 5

ALCOHOL WIPE
isopropyl alcohol swab

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0143-04	0.4 mL in 1 POUCH; 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 5

STING RELIEF PAD
ethyl alcohol, lidocaine swab

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0733-00	0.4 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/23/2017

Part 5 of 5

PVP IODINE WIPE
povidone-iodine 10% swab

Product Information
Item Code (Source)	NDC:0498-0121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
NONOXYNOL-9 (UNII: 48Q180SH9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0121-00	0.3 mL in 1 POUCH; 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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/13/2018

Labeler - Honeywell Safety Products USA, Inc. (118768815)

0498-4311: First Aid Kit (Burn Jel, alcohol wipes, PVP wipes, sting relief, EW- SF00004446)

Burn Jel Active ingredient

Burn Jel Purpose

Burn Jel Uses

Burn Jel Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Burn JEl Directions

Burn Jel Other information

Burn Jel Inactive ingredients

Burn Jel Questions

Sting Relief Active ingredient (in each wipe)

Sting Relief Purposse

Sting Relief Uses

Sting Relief Warnings

Do not use

Stop use and ask a doctor

Keep out of reach of children.

Sting Relief Directions

Sting Relief Inactive ingredients

Sting Relief Questions or Comments?

Eyewash Active ingredient

Eyewassh Purpose

Eyewash Uses

Eyewash Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children

Eyeash Directions

Eyewash Inactive ingredients

Eyeash Questions

Alcohol Active ingredient

Alcohol Purpose

Alcohol Uses

Alcohol Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and consult a doctor if

Keep out of reach of children

Alcohol Directions

Alcohol Other information

Alcohol Inactive ingredient

Alcohol Questions

PVP Active ingredient

PVP Purpose

PVP Uses

PVP Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

PVP Directions

PVP Other information

PVP Inactive ingredients

4311 SF00004446 Kit Contents

Burn Jel Principal Display Panel

Sting Relief Principal Display Panel

Eyewash Principal Display Panel

Alcohol Principal Display Panel

PVP Principal Display Panel

4311 Kit Label SF00004446

Burn Jel
Active ingredient

Burn Jel
Purpose

Burn Jel
Uses

Burn Jel
Warnings

Burn JEl
Directions

Burn Jel
Other information

Burn Jel
Inactive ingredients

Burn Jel
Questions

Sting Relief
Active ingredient (in each wipe)

Sting Relief
Purposse

Sting Relief
Uses

Sting Relief
Warnings

Sting Relief
Directions

Sting Relief
Inactive ingredients

Sting Relief
Questions or Comments?

Eyewash
Active ingredient

Eyewassh
Purpose

Eyewash
Uses

Eyewash
Warnings

Eyeash
Directions

Eyewash
Inactive ingredients

Eyeash
Questions

Alcohol
Active ingredient

Alcohol
Purpose

Alcohol
Uses

Alcohol
Warnings

Alcohol
Directions

Alcohol
Other information

Alcohol
Inactive ingredient

Alcohol
Questions

PVP
Active ingredient

PVP
Purpose

PVP
Uses

PVP
Warnings

PVP
Directions

PVP
Other information

PVP

Inactive ingredients

4311
SF00004446 Kit Contents

Burn Jel
Principal Display Panel

Sting Relief
Principal Display Panel

Eyewash
Principal Display Panel

Alcohol
Principal Display Panel

PVP
Principal Display Panel

4311 Kit Label
SF00004446