First Aid Burn Cream
Active ingredient

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
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

4128
SF00004238 Kit Contents

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

4 BZK ANTISEPTIC WIPE, BULK

4 FIRST AID CREAM 1.0GR PKT EACH

1 KIT PP PROMOTIONAL FA KIT

10 ADH BANDAGE 3/8" X 1 1/2" DNX

8 PLASTIC BANDAGE 3/4" X 3"

2 WOVEN KNUCKLE BANDAGE

2 HEAVY FLEX LARGE PATCH 2" X 3"

First Aid Burn Cream
Principal Display Panel

FABC label

BZK
Principal Display Panel

Antiseptic Wipe

4128 Kit Label
SF00004238

4128 Label

4128 FIRST AID KIT
4128 first aid kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-4128

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-4128-01	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	5.4 mL

Part 1 of 2

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 2

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

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)

0498-4128: First Aid Kit (BZK wipes, FABC- SF00004238)

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

4128 SF00004238 Kit Contents

First Aid Burn Cream Principal Display Panel

BZK Principal Display Panel

4128 Kit Label SF00004238

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

4128
SF00004238 Kit Contents

First Aid Burn Cream
Principal Display Panel

BZK
Principal Display Panel

4128 Kit Label
SF00004238