The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid Llc for the product Protection (NDC 52124-0114). 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, storage and handling, otc - do not use, otc - stop use, otc - keep out of reach of children, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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: 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.
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 drugFlammable - keep away from fire or flame
Other information: Store at room temperature
15 - 30 degree Celsius (59 - 86 Farenheit)
Flammable - keep away from fire or flame.
Store at room temperature
tamper evident sealed packets
do not use any opened or torn packets
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
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
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.
Directions: Wipe injection site vigorously and
Inactive Ingredient: Purified water
Inactive ingredients flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose
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
Alcohol Cleansing
Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Alcoholcleansingpad (Alcoholcleansingpad)
Insect Sting
Relief Pad
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
2 Tablets
GENUINE FIRST AID.
Chewable Aspirin 81mg
Chewableaspirin (Chewableaspirin)
Protection
2 Medical Grade Vinyl Gloves
1 Instant Cold Compress
2 Alcohol Cleansing Pads
1 Insect Sting Relief Pads
1 Emergency Blanket 38"x60"
2 Chewable Aspirin Tablets
1 Triangular Bandage 42"X42"x59"
Manufactured in China for:
Genuine First Aid LLC.
600Cleveland Street
Suite 400
Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
Copyright c 2009 Genuine First Aid LLC. All rights reserved.
Kit5 Protection (Kit5protection)
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.
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.
* Please review the disclaimer below.
