Small Cuts And Burns (Benzalkonium Chloride, Lidocaine, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) Kit [Genuine First Aid Llc] -

SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]
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NDC	52124-0001-1, 52124-0003-1, 52124-0004-1, 52124-0116-1
Set ID	25292d39-7914-4ef1-b6a0-a7ddff8985e5
Category	HUMAN OTC DRUG LABEL
Packager	Genuine First Aid LLC
Generic Name
Product Class	Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number	PART333

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ACTIVE INGREDIENT

Active Ingredients:

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%
PURPOSE

Purpose: First aid antiseptic, external analgesic

Uses: First aid to help prevent infection and for
the temporary relief of pain and itching associated with:
minor cuts, scrapes, burns
WARNINGS

Warning: For external use only.
DO NOT USE

Do not use: in eyes, in large quantities, over raw blistered areas,

or on deep puncture wounds, animal bites or serious burns, for more than one week
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If ingested, contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION

Directions: Clean affected area, Apply small amount not more than 3 times daily.

May be covered with a sterile bandage.
STORAGE AND HANDLING

Other Information:

Store at room temperature
DESCRIPTION

LOT/EXP: Made in CHINA

20130301
PRINCIPAL DISPLAY PANEL

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.
PRINCIPAL DISPLAY PANEL
ACTIVE INGREDIENT

Active Ingredient: Purpose

Benzalkonium Chloride 0.40%... First Aid Antiseptic
PURPOSE

Use: For Professional and Hospital use. Helps

prevent infection. Antiseptic cleansing of face,

hands and body without soap and water.
WARNINGS

Warning: For external use only.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: If swallowed, get medical help

or contact a Poison Control Center right away.
STOP USE

Stop use if unusual redness, swelling or other symptoms occur.
Consult a physician immediately.
DO NOT USE

Do not use in the eyes or over large areas of

the body.
WHEN USING

Directions: Tear open packet, unfold towelette

and use to cleanse desired skin area. Discard

towelette appropriately after single use.
INACTIVE INGREDIENT

Inactive Ingredient: Purified water
DESCRIPTION

LOT/EXP: Made in CHINA

20130301
PRINCIPAL DISPLAY PANEL

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID
PRINCIPAL DISPLAY PANEL
ACTIVE INGREDIENT

Active Ingredient: .........Bacitracin Zinc 400 units

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

Polymyxin B Sulfate 5000 units
PURPOSE

Uses: To help prevent infection in:
minor cuts; scrapes; burns
WARNINGS

Warnings:

For external use only.
DO NOT USE

Do not use: in eyes; over large areas of the body;

If allergic to any of the ingredients; for more than one week unless directed by a physician.
STOP USE

Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.
WHEN USING

Directions: clean affected area; apply small amount of this 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
STORAGE AND HANDLING

Other information:

Store at room temperature.
PRINCIPAL DISPLAY PANEL

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

Small Cuts and Burns
10 Adhesive Plastic Bandages 3/4"x3"
10 Junior Plastic Bandages 3/8"x1-1/2"
5 Adhesive Plastic Bandages 1"x3"
1 Knuckle Fabric Bandage
10 Adhesive Spot Bandages 7/8"x7/8"
1 Fingertip Fabric Bandage
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
5 Antiseptic Towelettes
1 Antibiotic Ointment
2 Sterile Gauge Pads 2"x2"
10 Cotton Tipped Applicators

Manufactured in China for:

Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID
Copyright 2009 Genuine First Aid LLC. All rights reserved.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMALL CUTS AND BURNS
benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52124-0116

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52124-0116-1	1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKAGE	0.9 g
Part 2	5 PACKAGE	4 mL
Part 3	1 TUBE	0.5 g

Part 1 of 3

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE
benzalkonium chloride, lidocaine cream

Product Information
Item Code (Source)	NDC:52124-0004
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 (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52124-0004-1	0.9 g in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part345	04/23/2010

Part 2 of 3

ANTISEPTIC TOWELETTE
benzalkonium chloride liquid

Product Information
Item Code (Source)	NDC:52124-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.40 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52124-0001-1	0.8 mL in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	04/23/2010

Part 3 of 3

GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC:52124-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B SULFATE	5000 [iU] in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52124-0003-1	0.5 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	04/23/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	04/23/2010

Labeler - Genuine First Aid LLC (619609857)

Name	Address	ID/FEI	Business Operations
Establishment
GFA Production ( Xiamen) Co., Ltd		421256261	manufacture

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Medic

SMALL CUTS AND BURNS (BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GENUINE FIRST AID LLC]

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