FDA Label for Medium Cuts And Scratches

View Indications, Usage & Precautions

Medium Cuts And Scratches Product Label

The following document was submitted to the FDA by the labeler of this product Genuine First Aid Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient:                             Purpose

Benzalkonium Chloride 0.40%......First Aid Antiseptic

Active Ingredient:

Purified Water USP...q.s.


Otc - Purpose



Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Uses:

For flushing or irrigating the eyes to

remove loose foreign material, air pollutants,

or chlorinated water.


Warnings



Warning:    For external use only.

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.


Otc - 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.

Otc - Stop Use



Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.


Otc - Do Not Use



Do not use in the eyes or over large areas of the body.


Otc - 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

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)


Description



LOT/EXP:                                    Made in CHINA

20130301

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:


Package Label.Principal Display Panel



Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

10ml

Sterile Isotonic Buffered Genuine

 Eyewash

For single use only

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.


Storage And Handling



Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.


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.


* Please review the disclaimer below.