FDA Label for The New Parent First Aid

View Indications, Usage & Precautions

The New Parent First Aid Product Label

The following document was submitted to the FDA by the labeler of this product American Red Cross. 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: .........Bacitracin Zinc 400 units

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

Polymyxin B Sulfate 5000 units

Active Ingredient:                                        Purpose

Isopropyl Alcohol, 70% v/v...............        Antiseptic

Active Ingredient:

Ethyl Alcohol 62 percent


Otc - Purpose



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

Use:    For preparation of skin before injection.

Uses: For hand washing to decrease bacteria on the skin


Warnings



Warnings:

For external use only.

Warnings:    For external use only.

Warnings:

For external use only

Flammable, keep away from fire or flame


Otc - 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.

Do not use: with electrocautery, in the eyes.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.


Otc - Stop Use



Stop use and consult a doctor:

if the condition persists or gets worse;  a rash or other allergic reaction develops

Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Stop use and consult a doctor if irritation and redness develop

and persist for more than 72 hours.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

If ingested, 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 swallowed, get medical help or contact a Poison Control Center right away.


Otc - 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

Wipe Injection site vigorously and discard.


Storage And Handling



Other information:

Store at room temperature.

Flammable - keep away from fire or flame

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)


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


Package Label.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.

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Genuine Hand Sanitizer

Instant Gel

Antiseptic Handwash

with Vitamin E and Aloe

Kills 99.9 percent of germs

Without Water

Active Ingredient:
Ethyl Alcohol 62 percent

Net Wt 0.9g (1/32 oz)

Manufactured in China For

Genuine First Aid.

first years

Ready, Set, Help: The First Years will pay 2-3% of the purchase price of this product to the American Red Cross.  To learn more about the American Red Cross visit: redcross.org

The New Parent First Aid Kit includes 118 emergency and first aid essentials, with special emphasis on infant and toddler care.  The sturdy storage case is ideal for restocking when supplies get low.  Be sure to:

-Check the kit regularly

-Check expiration dates and replace any used or out-of date items.

-Check batteries in mini-flash light and replace when necessary (2 AAA alkaline batteries recommended)

-Always store y our first aid kit in a secure place out of reach of young children

New Parent Resources
Infant and Child CPR Training teaches parents, expectant parents, nannies, babysitters and family members to prevent, recognize and provide care for breathing and cardiac emergencies in infants and children age 12 and under.  Includes hands-on practice.

Visit redcross.org or contact your local American Red Cross chapter for more information about first aid, CPR courses and products to keep your family safe.

The American Red Cross logo is a trademark owned by the American Red Cross.  Officially licensed product of the American Red Cross

Questions? Comments? Call us toll-free at 1-800-704-8697 or visit us at www.learningcurve.com

WARNING: Except for infant rattle, contents are not toyes.  Keep out of reach of children.

Actual product styling and colors may vary.  Please retain this packaging for future reference.

The First Years
c 2008 Learning Curve Brands, Inc.
100 Technology Center Drive
Stoughton, MA 02072, U.S.A.
All rights reserved
Made in India.  ARC7058
Y705IC-OPL_BACK

Contents:
1 Emergency First Aid Guide
60 Adhesive Bandages
10 Triple Antibiotic Ointment packets
18 Sterile Gauze Pads (2x2, 3x3, 4x4)
2 Sterile Roller Bandages (3"w,4"w)
1 Adhesive Tape
1 Scissors
1 Tweezers
1 Mini-flashlight (2 AAA batteries included)
1 Instant Cold Pack
10 Alcohol Pads
10 Waterless Hand Sanitizers
1 Small, Cloth Blanket
1 Nasal Aspirator
1 Infant Toy Rattle
1 Travel/Storage Case

Product usage and care instructions inside
Refer to warning on individual products contained with this kit



Inactive Ingredient



Inactive Ingredient:    Purified water.


Description



LOT/EXP:                Made in CHINA

20140301


Dosage & Administration



Directions:

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


* Please review the disclaimer below.