Arc First Aid Contains 1000 Pieces
FDA Label NDC 52164-1108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Red Cross for the product Arc First Aid Contains 1000 Pieces (NDC 52164-1108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

Burncream (Burncream)

Burncream (Burncream)

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Antiseptic Towelette (Antiseptictowelette)

Antiseptic Towelette (Antiseptictowelette)

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.

Genuinetripleantibiotic (Genuinetripleantibiotic)

Genuinetripleantibiotic (Genuinetripleantibiotic)

10ml

Sterile Isotonic Buffered Genuine

 Eyewash

For single use only

Genuineeyewash (Genuineeyewash)

Genuineeyewash (Genuineeyewash)

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Alcoholcleansingpad (Alcoholcleansingpad)

Alcoholcleansingpad (Alcoholcleansingpad)

Insect Sting Relief Pad

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

1/pouch

GENUINE FIRST AID

Insect Sting Relief Pad (Insectstingreliefpad)

Insect Sting Relief Pad (Insectstingreliefpad)

 2 Tablets

GENUINE FIRST AID.

Chewable Aspirin 81mg

Chewable Aspirin 81mg (Chewableaspirin)

Chewable Aspirin 81mg (Chewableaspirin)

American Red CrossCONTAINS 1000 PIECESFIRST AID KITCLEAN . TREAT . PROTECTHOME        PLAY    AUTO     OFFICE    WORK  All Purpose KitNew ORGANIZED POCKETS FOR EMERGENCY ACCESS 1 SMALL CUTS 2 MEDIUM CUTS 3 MEDIUM BURNS AND SCRATCHES4 SEVERE BLEEDING AND BURNS5 PROTECTION AND CPR6 INSTRUMENTS           ANDEASY REFILL SYSTEMREFILL PACKS AVAILABLE FOR EACH POCKET   Carrying Case1 Soft-side Bag1 Easy Access Pocket System    Small Cuts and Burns80 Adhesive Plastic Bandages 3/4"x3"580 Junior Plastic Bandages 3/8"x1-1/2"200 Adhesive Spot Bandages 7/8"x7/8"20 Adhesive Plastic Bandages 1"X3"2 Knuckle Fabric Bandages2 Fingertip Fabric Bandages2 Elbow/Knee Adhesive Bandage     Medium Cuts and Scratches40 Cotton Tipped Applicators1 Triple Antibiotic Ointment 0.9gr1 Burn Cream4 Sterile Gauze Pad 2"X2"20 Antiseptic Towelettes1 Roller Gauze Bandages 2"X4.1yds2 Sterile Eye Pads1 Sterile Eye Wash 10ml   Severe Bleeding and Burns2 Sterile Gauze Pads 3"X 3"2 Sterile Gauze Pads 4"X 4"1 First Aid Tape Roll 1/2"x 2.5yds1 Combine Pad 5"X9"1 Combine Pad 8"X10"1 Roller Gauze Bandages 3"X4.1yds4 Butterfly Wound Closures   CPR1 CPR Breathing BarrierProtection and CPR4 Medical Grade Vinyl Gloves1 Instant Cold Compress6  Alcohol Cleansing Pads1 Insect Sting Relief Pads1 Emergency Blanket 38"X 60"4 Chewable Aspirin Tablets1 Triangular Bandage 42"x42"x59"   Instruments1 Emergency First Aid Guide1 Plastic Tweezers1 Scissors6 Assorted Safety Pins2 Wooden Finger SplintsCopyright c 2009 Genuine First Aid LLC. All rights reserved.Manufactured in China for:Genuine First Aid LLC.600 Cleveland StreetSuite 400Clearwater, FL 33755www.GenuineFirstAid.comGENUINE FIRST AID

Arc Kit 1000 (Arckit1000)

Arc Kit 1000 (Arckit1000)

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.