MEDIUM CUTS AND SCRATCHES- benzalkonium chloride, water kit

Medium Cuts and Scratches by

Drug Labeling and Warnings

Medium Cuts and Scratches by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid LLC, GFA Production ( Xiamen) Co., Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

1/pouch

GENUINE FIRST AID

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient:

Purified Water USP...q.s.

INACTIVE INGREDIENT

Inactive Ingredients:

Sodium Chloride USP                                          44mg

Monobasic Sodium Phosphate USP                18mg
Sodium Phosphate Dibasic USP                       111mg  

Edetate Disodium USP                                       10mg

Benzalkonium Chloride                                      0.5mg
NF (as preservative)

STORAGE AND HANDLING

Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.

WARNINGS

Warning:

If you experience eye pain, changes in vision, continued redness or irritation of the eye,

or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Do not use if solution changes color or becomes cloudy.

DOSAGE & ADMINISTRATION

Directions

Remove contacts before using.

Twist top to remove.

Flush the affected area as needed. Control

Rate of flow by pressure on the bottle. Do not touch

tip of the container to any surface. Do not reuse.

If necessary continue flushing with emergency eyewash or shower.

Discard bottle after use.

PURPOSE

Uses:

For flushing or irrigating the eyes to

remove loose foreign material, air pollutants,

or chlorinated water.

DESCRIPTION

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:

PRINCIPAL DISPLAY PANEL

10ml

Sterile Isotonic Buffered Genuine

 Eyewash

For single use only

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Medium Cuts, Burns and Severe Bleeding

5 Antiseptic Towelette
2 Sterile Gauge Pad 2"x2"
2 Sterile Gauge Pad 3"x3"
2 Sterile Gauge Pad 4"x4"
1 Roller Gauge Bandage 2"x4.1 yds.
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
2 Butterfly Wound Closures

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

MEDIUM CUTS AND SCRATCHES 
benzalkonium chloride, water kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-0117

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0117-1	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	5 PACKAGE	4 mL
Part 2	1 BOTTLE	10 mL

Part 1 of 2

ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid

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

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

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

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

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

Part 2 of 2

STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
water liquid

Product Information
Item Code (Source)	NDC: 52124-0005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	98.16 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0005-1	10 mL in 1 BOTTLE

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

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

Labeler - Genuine First Aid LLC (619609857)

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