Genuine First Aid - Home First Aid
FDA Label NDC 52124-1200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid, Llc for the product Genuine First Aid - Home First Aid (NDC 52124-1200). 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.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:                                        Purpose

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

Active Ingredient: .........Bacitracin Zinc 400 units

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

Polymyxin B Sulfate 5000 units


Active ingredient (in each tablet)                       Purpose

Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Active Ingredient (in each tablet)                      Purpose

Acetaminophen 500 mg...............................   Pain Reliever / fever reducer


Active Ingredient:                                 Purpose

Benzalkonium Chloride 0.40%..........   First Aid Antiseptic

Otc - Purpose

Use:    For preparation of skin before injection.

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

Uses temporarily relieves minor aches and pains due to:the common coldheadachetoothachemuscular achesbackacheminor pain of arthritismenstrual cramps temporarily reduces fever

Purpose: Pain reliever, fever reducer

Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warnings

Warnings:    For external use only.

Warnings:

For external use only.



Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach
bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed

Warnings

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

Warning:   For external use only.

Storage And Handling

Flammable - keep away from fire or flame

Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

Other information:

Store at room temperature.

Other information:  Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

Otc - Do Not Use

Do not use: with electrocautery, in the eyes.

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 if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

Do not use:  with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

Do not use in the eyes or over large areas of the body.

Otc - Stop Use

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

Stop use and consult a doctor:

if the condition persists or gets worse;  a rash or other allergic reaction develops

Stop use and ask a doctor If:you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Otc - Keep Out Of Reach Of Children

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. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

Wipe Injection site vigorously and discard.

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

When using this product:take with food or milk if stomach upset occurs

Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


Inactive Ingredient

Inactive Ingredient:    Purified water.

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

Inactive Ingredient:   Purified water


Description

LOT/EXP:                Made in CHINA

20140301

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

LOT/EXP:                           Made in CHINA

20130301

Package Label.Principal Display Panel

Alcohol Cleansing  Pad
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.

IBUPROFEN 2 Tablets

IBUPROFEN   2 Tablets

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Antiseptictowelette (Antiseptictowelette)

Antiseptictowelette (Antiseptictowelette)

Genuinetripleantibiotic (Genuinetripleantibiotic)

Genuinetripleantibiotic (Genuinetripleantibiotic)

Ibuprofen 200mg (Ibuprofen)

Ibuprofen 200mg (Ibuprofen)

Alcoholcleansingpad (Alcoholcleansingpad)

Alcoholcleansingpad (Alcoholcleansingpad)

Otc - Ask Doctor

Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are:taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swellign is present

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

If pregnant or breast-feeding, ask a health professional before use.

Dosage & Administration

Directions:
do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.


Adults and children: (12 years and older)
take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:
do not give to children under 12 years of age.

Indications & Usage

Uses   for the temporary relief of minor aches and pains associated with
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

* Please review the disclaimer below.