The following Structured Product Label (SPL) was submitted to the FDA by American Red Cross for the product Arc First Aid Contains 101 Pieces Hardcase (NDC 52164-1103). 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.
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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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:
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.
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
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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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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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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Genuine First Aid Burn Cream
Antiseptic Pain Relief With Aloe
Net Wt 0.9g (1/32 oz)
Manufactured in CHINA for
Genuine First Aid.
Burn Cream (Burncream)
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Antiseptic Towelette (Antiseptictowelette)
10ml
Sterile Isotonic Buffered Genuine
Eyewash
For single use only
Genuineeyewash (Genuineeyewash)
Alcohol Cleansing Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Alcoholcleansingpad (Alcoholcleansingpad)
2 Tablets
GENUINE FIRST AID.
Chewable Aspirin 81mg
Chewable Aspirin 81 mg (Chewableaspirin)
American Red Cross
Carrying Case
1 Soft-side Bag
1 Easy Access Pocket System
Small Cuts and Burns
25 Adhesive Plastic Bandages 3/4"x3"
25 Junior Plastic Bandages 3/8"x1-1/2"
1 Adhesive Plastic Bandage 1"x3"
1 Adhesive Spot Bandage 7/8"x7/8"
1 Elbow/Knee Adhesive Bandage
1 Burn Cream
20 Cotton Tipped Applicators
Medium Cuts and Scratches
1 Antiseptic Towelettes
1 Sterile Gauge Pad 2"x2"
1 Roller Gauge Bandage 2"x4.1yds.
1 Sterile Eye Pad
1 Sterile Eye Wash 10ml
2 Butterfly Wound Closure
Severe Bleeding and Burns
1 First Aid Tape Roll 1/2"x2.5 yds.
1 Combine Pad 5"x9"
1 Roller Gauge Bandage 3"x4.1yds
CPR
1 CPR Breathing Barrier
Protection
2 Medical Grade Vinyl Gloves
1 Alcohol Cleansing Pad
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"x42"x59"
Instruments
1 Emergency First Aid Guide
6 Assorted Safety Pins
1 Plastic Tweezers
Visit RedCross.org for information on training in First Aid, CPR, AED and more
Manufactured in China for:
Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Copyright c 2009 Genuine First Aid LLC. All rights reserved.
Arckit101hardcase (Arckit101hardcase)
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
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: 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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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
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
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.
