FDA Label for First Aid Contains 101 Pieces

View Indications, Usage & Precautions

First Aid Contains 101 Pieces 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 INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Active Ingredient:                                            Purpose

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

Active Ingredient:

Purified Water USP...q.s.

Active Ingredient:                                        Purpose

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

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Otc - 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

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 wate

Use:    For preparation of skin before injection.

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Warnings



Warnings:

For external  use only

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.

Warnings:    For external use only.   

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness.
Stomach bleeding warning:  This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.  The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.


Otc - 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

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

Do not use: with electrocautery, in the eyes.

Do not use

if you are allergic to aspirin or any other pain relievers/fever reducers

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

for at least 7 days after a tonsillectomy or oral surgery


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.

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Dosage & Administration



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

May be covered with a sterile bandage.

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.

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Storage And Handling



Other Information:

Store at room temperature

Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.

Flammable - keep away from fire or flame

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

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Package Label.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.

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

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

2 Tablets

GENUINE FIRST AID.

Chewable Aspirin 81mg

GENUINE FIRST AID.

CONTAINS 101 PIECES

FIRST AID KIT

CLEAN . TREAT . PROTECT

With 6 First Aid Pockets

NEW! REFILL PACKS AVAILABLE FOR EACH POCKET

1 Small Cuts and Burns

2 Medium Cuts and Scratches

3 Severe Bleeding and Burns

4 CPR

5 PROTECTION

6 Instruments

HOME   PLAY   AUTO  OFFICE   WORK

All Purpose Kit

Soft - Sided Storage Case

With Pockets that are Organized for Quick and Easy Emergency Access

CARRYING CASE     
1 Soft - Side Bag
1 Easy Access Pocket System

POCKET 1
SMALL CUTS AND BURNS
25 Adhesive Plastic Bandages 3/4"x3"
25 Junior Plastic Bandages 3/8"x1-1/2"
1 Adhesive Plastic Bandages 1"x3"
1 Adhesive Spot Bandage 7/8"x7/8"
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
1 Antiseptic Towelette
1 Sterile Gauze Pad 2"x2"
20 Cotton Tipped Applicators

POCKET 2:
MEDIUM CUTS AND SCRATCHES
1 Antiseptic Towelette
1 Pressure Bandage 2"x2"
1 Pressure Bandage 3"x3"
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
1 Butterfly Wounded Closure

POCKET 3:
SEVERE BLEEDING AND BURNS
1 First Aid Tape Roll 1/2"x2.5 yds
1 Bloodstopper Dressing

POCKET 4:
CPR
1 CPR Breathing Barrier

POCKET 5:
PROTECTION
2 Medical Grade Gloves
1 Alcohol Cleaning Pad
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"x42"x59"

POCKET 6:
INSTRUMENTS
1 Emergency First Aid Guide
1 Plastic Tweezers
6 Assorted Safety Pins

Manufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater, FL 33755
www.GenuineFirstAid.com

Copyright c 2010 Genuine First Aid LLC. All rights reserved.







Otc - Stop Use



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

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Stop use and ask a doctor if;

an allergic reaction occurs, Seek medical help right away

pain or fever persists

new or unexpected symptoms occur

redness or swelling is present

ringing in ears or loss of hearing occurs


Otc - When Using



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

Wipe Injection site vigorously and discard.


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)

Inactive Ingredient:    Purified water.

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Description



LOT/EXP:                                    Made in CHINA

20130301

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:

LOT/EXP:                Made in CHINA

20140301

MADE IN USA

Distributed by GENUINE FIRST AID

600 Cleveland Str Suite 400, Clearwater, FL 33755


Otc - Ask Doctor



Ask a doctor before use if you have;

asthma

stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

a child experiencing arthritis pain

if you are;

allergic to aspirin

taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.


Microbiology




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