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

Other information

tamper evident sealed packets
do not use if packet is opened or torn

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

Questions

1-800-430-5490

Neomycin Antibiotic Ointment
Active ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin Antibiotic Ointment
Purpose

First aid antibiotic

Neomycin Antibiotic Ointment
Uses

first aid to help prevent infection in - minor cuts - scrapes - burns

Neomycin Antibiotic Ointment
Warnings

For external use only

Do not use

in the eyes
over large areas of the body

Ask a doctor before use if you have

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 reach of children

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

Neomycin Antibiotic Ointment
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

Neomycin Antibiotic Ointment
Other information

store at 15 o to 25 oC (59 o to 77 oF)

Neomycin Antibiotic Ointment
Inactive ingredient

petrolatum

Neomycin Antibiotic Ointment
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

PVP
Questions

800-430-5490

4351
018503-4219 Kit Contents

1 TWEEZER PLASTICS 4"

2 O/H PAK,ADH BDG 2"X4", X-LG

6 PVP PREP PADS MEDIUM

1 SCISSOR BDGE 4" RED PLS HDL

1 PR LRG NITRILE GLVES ZIP BAG

4 FIRST AID CREAM 1.0GR PKT EACH

1 TAPE ADHESIVE 1/2 X 2.5 125133

4 POUCH NEOMYCIN ANTIBIOTIC .9 G

1 KIT BAG SOFT PACK PROMO

1 INSRT POCKET KIT PROD INF ID C

1 COLD PACK UNIT 4"X6" BULK

2 GAUZE PADS 3"X3" 12PLY

2 WOVEN FINGERTIP BANDAGE 2"

2 WOVEN KNUCKLE BANDAGE

10 WOVEN BANDAGE 1" X 3"

First Aid Burn Cream
Principal Display Panel

First Aid Burn Cream

Neomycin Antibiotic Ointment
Principal Display Panel

Neomycin

PVP
Principal Display Panel

PVP Wipe

4351 Kit Label
018503-4219

4351 label

4351 FIRST AID KIT
4351 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4351

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4351-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	4 PACKET	3.6 g
Part 2	4 PACKET	3.6 g
Part 3	6 POUCH	1.8 mL

Part 1 of 3

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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

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

#	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
unapproved drug other		12/20/2017

Part 2 of 3

NEOMYCIN
antibiotic ointment

Product Information
Item Code (Source)	NDC:0498-0730
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0730-01	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
unapproved drug other		03/31/2010

Part 3 of 3

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
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	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		10/18/2018

Labeler - Honeywell Safety Products USA, INC (118768815)

0498-4351: First Aid Kit (Neomycin, FABC, PVP- 018503-4219)

First Aid Burn Cream Active ingredient

First Aid Burn Cream Purpose

First Aid Burn Cream Uses

First Aid Burn Cream Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

First Aid Burn Cream Directions

Other information

Inactive ingredients

Questions

Neomycin Antibiotic Ointment Active ingredient

Neomycin Antibiotic Ointment Purpose

Neomycin Antibiotic Ointment Uses

Neomycin Antibiotic Ointment Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

Neomycin Antibiotic Ointment Directions

Neomycin Antibiotic Ointment Other information

Neomycin Antibiotic Ointment Inactive ingredient

Neomycin Antibiotic Ointment 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

PVP Questions

4351 018503-4219 Kit Contents

First Aid Burn Cream Principal Display Panel

Neomycin Antibiotic Ointment Principal Display Panel

PVP Principal Display Panel

4351 Kit Label 018503-4219

First Aid Burn Cream
Active ingredient

First Aid Burn Cream
Purpose

First Aid Burn Cream
Uses

First Aid Burn Cream
Warnings

First Aid Burn Cream
Directions

Neomycin Antibiotic Ointment
Active ingredient

Neomycin Antibiotic Ointment
Purpose

Neomycin Antibiotic Ointment
Uses

Neomycin Antibiotic Ointment
Warnings

Neomycin Antibiotic Ointment
Directions

Neomycin Antibiotic Ointment
Other information

Neomycin Antibiotic Ointment
Inactive ingredient

Neomycin Antibiotic Ointment
Questions

PVP
Active ingredient

PVP
Purpose

PVP
Uses

PVP
Warnings

PVP
Directions

PVP
Other information

PVP
Inactive ingredients

PVP
Questions

4351
018503-4219 Kit Contents

First Aid Burn Cream
Principal Display Panel

Neomycin Antibiotic Ointment
Principal Display Panel

PVP
Principal Display Panel

4351 Kit Label
018503-4219