FDA Label for Blue Acme Sleeve First Aid Contains 1000 Pieces

View Indications, Usage & Precautions

Blue Acme Sleeve First Aid Contains 1000 Pieces Product Label

The following document was submitted to the FDA by the labeler of this product Acme United Corp.. 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: .........Bacitracin Zinc 400 units

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

Polymyxin B Sulfate 5000 units

Active Ingredient:

Purified Water USP...q.s.

Active Ingredient:                                        Purpose

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

Active Ingredient:                                    Purpose:

Benzocaine, 6% w/v..................    Topical Anesthetic

SD alcohol, 60% w/v..................    Antiseptic

Active ingredient (in each tablet)                           Purpose

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic

*nonsteroidal anti-inflammatory drug


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

Uses:

For flushing or irrigating the eyes to

remove loose foreign material, air pollutants,

or chlorinated water.

Use:    For preparation of skin before injection.

Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Uses

temporary relief of minor aches, pains and headaches

to reduce fever associated with colds, sore throats, teething


Warnings



Warnings:

For external  use only

Warning:    For external use only.

Warnings:

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: For external use only.

Avoid contact with eyes.  If this happens, rinse thoroughly with water.

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:  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 eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

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 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.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.


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.

Directions  Do not use more than directed

Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children Under 12 years: Consult a doctor.


Storage And Handling



Other Information:

Store at room temperature

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)

Flammable - keep away from fire or flame.

Store at room temperature

tamper evident sealed packets

do not use any opened or torn packets


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

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.

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

Insect Sting Relief Pad

Genuine First Aid LLC, Clearwater FL 33755
                        www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

 2 Tablets

GENUINE FIRST AID.

Chewable Aspirin 81mg

PhysiciansCARE

FIRST AID
all purpose kit
with 6 First Aid Pockets

1 Small Cuts and Burns

2 Medium Cuts and Scratches

3 Severe Bleeding and Burns

4 CPR

5 Protection

6 Instruments

New
REFILL PACKS AVAILABLE FOR EACH POCKET

HOME        PLAY    AUTO     OFFICE    WORK  

CONTAINS 1000 PIECES

Soft-Sided Storage Case

With Pockets that are Organized for Quick and Easy Emergency Access

CARRYING CASE
1 Soft-side Bag
1 Inside Plastic Pockets

SMALL CUTS AND BURNS
Pocket One
300 Adhesive Plastic Bandages 3/4"x3"
295 Junior Plastic Bandages 3/8"x1-1/2"
90 Adhesive Plastic Bandages 1"x3"
5 Knuckle Fabric Bandages
180 Adhesive Spot Bandages 7/8"x7/8"
6 Fingertip Fabric Bandages
6 Elbow/Knee Adhesive Bandage
1 Burn Cream
14 Antiseptic Towelettes
4 Triple Antibiotic Ointment
6 Sterile Gauze Pads 2''x2''
20 Cotton Tipped Applicatiors


MEDIUM CUTS AND SCRATCHES
Pocket Two
12 Antiseptic Towelettes
5 Sterile Gauze Pad 2"X2"
2 Sterile Gauze Pad 3"x3"
2 Sterile Gauze Pad 4"x4"
2 Roll Gauze Bandages 2"
2 Sterile Eye Pads
2 Sterile Eye Wash
5 Butterfly Wound Closures


SEVERE BLEEDING AND BURNS
Pocket Three
1 First Aid Tape Roll 1/2"
1 Combine Pad 5"x9"
1 Combine Pad 8"x10"
1 Roll Gauze Bandage 3"

CPR
Pocket Four
1 CPR Breathing Barrier

PROTECTION
Pocket Five
4 Medical Grade  Gloves
1 Instant Cold Compress
10 Alcohol Cleansing Pads
2 Insect Sting Relief Pads
1 Emergency Blanket 38"X 60"
4 Chewable Aspirin Tablets
1 Triangular Bandage 42"x42"x59"

INSTRUMENTS
Pocket Six
1 Emergency First Aid Guide
1 Plastic Tweezers
1 Scissors
6 Assorted Safety Pins
2 Wooden Finger Splints

CAUTION: This kit contains products that have expiration dates. Please check before using.

Acme United Corporation
60 Round Hill Road
Fairfield, CT 06824
www.acmeunited.com
Designed in USA / Made in India
2009 Acme United Corporation
PhysiciansCare and are Registered Trademrks
of Acme United Corporation



Otc - Stop Use



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

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

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.

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.


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.

Inactive ingredients        flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose


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 CHINA

LOT/EXP:

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.


* Please review the disclaimer below.