FDA Label for Emergency Preparedness

View Indications, Usage & Precautions

Emergency Preparedness 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:Ethyl Alcohol 62 %

Active Ingredient:                             Purpose

Benzalkonium Chloride 0.40%... First Aid Antiseptic

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

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

Polymyxin B Sulfate 5000 units


Otc - Purpose



Uses: For hand washing to decrease bacteria on the skin
Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Uses:  To help prevent infection

in * minor cuts * scrapes * burns


Warnings



Warnings:

For external use only

Flammable, keep away from fire or flame

Warning:    For external use only.

Warnings:

For external use only.


Otc - Do Not Use



Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
Do not use in the eyes or over large areas of the body.


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.


Otc - Stop Use



Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours.

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

Stop use and consult a doctor : if the condition persists or gets worse; a rash or other allergic

reaction develops


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.

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.


Dosage & Administration



Directions:

Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.

Storage And Handling



Other Information: Store at 15 to 25 degree Celsius  (59 to 77 degree Fahrenheit)

Other information:

Store at room temperature.


Package Label.Principal Display Panel



Genuine Hand SanitizerInstant GelAntiseptic Handwashwith Vitamin E and AloeKills 99.9 percent of germsWithout WaterNet Wt 0.9g (1/32 oz)Manufactured in China ForGenuine First Aid

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID


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.

Emergency Preparedness

2 Procedural Masks, 3 ply

1 Emergency Blanket 38" x 60"

1 Light Stick

4 Antiseptic Towelettes

1 Triple Antibiotic Ointment 0.9 gr

1 Hand Sanitizer 0.9 gr

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.


Otc - When Using



Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard
towelette appropriately after single use.




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


Inactive Ingredient



Inactive Ingredient:    Purified water


Description



LOT/EXP:                                    Made in CHINA

20130301


* Please review the disclaimer below.