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  5. Label Information: Gfa First Aid Kit Essentials - 33 Pieces

FDA Label for Gfa First Aid Kit Essentials - 33 Pieces

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTC - WHEN USING
    8. STORAGE AND HANDLING
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    10. OTC - ASK DOCTOR
    11. OTC - ASK DOCTOR/PHARMACIST
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. DOSAGE & ADMINISTRATION
    14. INACTIVE INGREDIENT
    15. DESCRIPTION
    16. ACTIVE INGREDIENT (IN EACH TABLET)
    17. PURPOSE
    18. USES
    19. DO NOT USE
    20. INACTIVE INGREDIENTS
    21. GENERAL PRECAUTIONS
    22. ACTIVE INGREDIENT
    23. USE
    24. DIRECTIONS
    25. OTHER

Gfa First Aid Kit Essentials - 33 Pieces Product Label

The following document was submitted to the FDA by the labeler of this product Genuine First Aid, Llc. 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 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

Aspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer

*nonsteroidal anti-inflammatory drug 

Active Ingredient:                                 Purpose

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


Otc - Purpose



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

Uses   Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

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

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

Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of 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.

Allergy alert:   Aspirin may cause a severe allergic reaction which may include:  hives, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:   This contains an 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 prescription or nonprescription 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

Warning:   For external use only.

Liver warning:   This product contains acetaminophen.

Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 3 or more alcoholic drinks every day while using this product

 For external use only.  


Otc - Do Not Use



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:  if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

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

Do not use: with electrocautery, in the eyes.


Otc - Stop Use



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 and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faint;  vomit blood; have bloody or black stools; have stomachpain that does not get better; pain gets worse or lasts more than 10 days;  fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear

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

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

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


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. In case of overdose, 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 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 accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt
medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.  Do not exceed recommended dosage

Keep out of reach of children.  If swallowed,

get medical help or contact a Poison Control

Center right away.


Otc - When Using



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

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

Directions

do not use more than directed

the smallest effective dose should be used

drink a full glass of water with each dose

do not take longer than 10 days, unless directed by a doctor


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



Storage And Handling



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); avoid

excessive heat and humidity;  tamper evident sealed packets;

Do not use any opened or torn packets

Store at 59-86 degree F (15-30 degree C)


Flammable - keep away from fire or flame

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


Package Label.Principal Display Panel



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

ASPIRIN 2 Tablets

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

GENUINE FIRST AID         2 Tablets

NON-ASPIRIN

Alcohol Cleansing Pad

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID




100 Alcohol cleansing pads

Reorder GFAP-39-02

AntisepticTowelette - towelette

AntisepticTowelette - towelette


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

Ask a doctor before use if the user has 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:

under a doctor's care for any serious condition;  taking any other drug

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin


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. It is especially important 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 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 1 or 2 tablets with

water every 4 hours as needed.  Do not take more than 12 tablets in 24

hours, or as directed by a doctor.

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

Directions

Adults and Children                        Take 2 tablets every 4 to 6 hours as

12 years of age                               needed.  Do not take more than 12 tablets

or older                                          in 24 hours.



Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

of age                                               needed.  Do not take more than 5

                                                        tablets in 24 hours.



Children under 6                                Do not use this regular strength product.

years of age                                      This will provide more than the

                                                         recommended dose (overdose) and could

                                                         cause serious health problems.


Inactive Ingredient



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:  hypromellose, polyethylene glycol, propylene glycol, corn starch

Inactive Ingredient:   Purified water


Purified water.


Description



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

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

LOT/EXP:                           Made in CHINA

20130301

Distributed by GENUINE FIRST AID600 Cleveland Str Suite 400, Clearwater, FL 33755

Active Ingredient (In Each Tablet)



Acetaminophen 325 mg


Purpose



Analgesic/antipyretic

Antiseptic


Uses




temporary relief of minor aches and pains associated with:

common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever


Do Not Use



with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist;  for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor


Inactive Ingredients



Cornstarch, polyethylene glycol, stearic acid, povidone


General Precautions



tamper evident sealed packets; do not use any open or torn packets


Active Ingredient



Active Ingredient:                                

Isopropyl Alcohol, 70% v/v


Use



 For preparation of skin before injection.


Directions



Wipe Injection site vigorously and discard.

Other



LOT/EXP:            Made in CHINA

20140301


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