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

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

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

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

irritation, redness or other symptoms develop
the condition persists or gets worse

BZK
Directions

tear open packet and use as a washcloth

BZK
Other information

store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
do not reuse towelette

BZK
Inactive ingredients

water

BZK
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

1-800-430-5490

4156
SF00000670 Kit Contents

1 FIRST AID BURN CREAM 6 PER

1 TRIANGULAR BDG, NON-STERILE

1 GAUZE PADS, 3" X 3", 4 PER

1 ADH TAPE, .5" X 2.5 YD, 2 PER

1 GAUZE COMP, 1 SQ YARD, 1 PER

1 INSTANT COLD PACK 4" X 6"

1 EYEWASH BOTTLES 1 OZ, UNITIZED 2/BX

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

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 ANTIMCRBL ANTSPTC TWLETTS

1 F. A. INST CHART SM (INDIVIDUAL LBL)

1 BANDAGE COMP 4" W/TELFA PAD 1

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 KIT, PP 16 UNIT FA

First Aid Burn Cream
Principal Display Panel

FABC label

BZK
Principal Display Panel

Antiseptic Wipe

PVP
Principal Display Panel

PVP Wipe

4156 Kit Label
SF00000670

4156 label

4156 FIRST AID KIT
4156 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4156

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4156-01	1 in 1 KIT; Type 0: Not a Combination Product	10/18/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	6 PACKET	5.4 g
Part 2	1 PACKET	1.4 mL
Part 3	10 POUCH	3 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
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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

#	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

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
unapproved drug other		09/18/2018

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
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		10/18/2018

Labeler - Honeywell Safety Products USA, INC (118768815)

0498-4156: First Aid Kit (BZK wipes, FABC, PVP wipe- SF00000670)

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

First Aid Burn Cream Other information

First Aid Burn Cream Inactive ingredients

First Aid Burn Cream Questions

BZK Active ingredient

BZK Purpose

BZK Uses

BZK Warnings

Do not use

Keep out of reach of children

Stop use and ask a doctor if

BZK Directions

BZK Other information

BZK Inactive ingredients

BZK 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

4156 SF00000670 Kit Contents

First Aid Burn Cream Principal Display Panel

BZK Principal Display Panel

PVP Principal Display Panel

4156 Kit Label SF00000670

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

First Aid Burn Cream
Other information

First Aid Burn Cream
Inactive ingredients

First Aid Burn Cream
Questions

BZK
Active ingredient

BZK
Purpose

BZK
Uses

BZK
Warnings

BZK
Directions

BZK
Other information

BZK
Inactive ingredients

BZK
Questions

PVP
Active ingredient

PVP
Purpose

PVP
Uses

PVP
Warnings

PVP
Directions

PVP
Other information

PVP
Inactive ingredients

PVP
Questions

4156
SF00000670 Kit Contents

First Aid Burn Cream
Principal Display Panel

BZK
Principal Display Panel

PVP
Principal Display Panel

4156 Kit Label
SF00000670