FDA Label for Arc First Aid Contains 1000 Pieces
View Indications, Usage & Precautions
Arc First Aid Contains 1000 Pieces 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 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
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.