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  5. Label Information: Easy Care First Aid Kit - Sports And Travel

FDA Label for Easy Care First Aid Kit - Sports And Travel

View Indications, Usage & Precautions

Table of Contents

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

Easy Care First Aid Kit - Sports And Travel Product Label

The following document was submitted to the FDA by the labeler of this product Tender Corp Dba Adventure Medical Kits. 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.

Active Ingredient



Active Ingredient:                        

Benzalkonium Chloride 0.40%


Purpose



Antiseptic

Triple Antibiotic


Use



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


Warnings



Warning:   For external use only.

Warnings: For external use only.

Avoid contact with eyes.  If this happens, rinse thoroughly with water.


For external use only.

Warnings:

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



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

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

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 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 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

Otc - Do Not Use



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

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:  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 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

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

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


Inactive Ingredients



Inactive Ingredient:   Purified water



Other



LOT/EXP:                           Made in CHINA

20130301


Package Label.Principal Display Panel



Antiseptic Towelette

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

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.



Triple Antibiotic Ointment 10pcs

Net wt. 0.9g (1/32oz)



100
Triple Antibiotic

GENUINE FIRST AID         2 Tablets

NON-ASPIRIN

IBUPROFEN 2 Tablets

IBUPROFEN   2 Tablets

Genuine Triple Antibiotic - tripleantibiotic

Genuine Triple Antibiotic - tripleantibiotic


Otc - Active Ingredient



Active Ingredient:                           Purpose:

Benzocaine, 6% w/v..................    Topical Anesthetic

SD alcohol, 60% w/v..................   Antiseptic

Active Ingredient (in each tablet)            Purpose

Acetaminophen 325 mg .............            Analgesic/antipyretic


Active ingredient (in each tablet)                       Purpose

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

*nonsteroidal anti-inflammatory drug


Otc - Purpose



Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Uses

temporary relief of minor aches and pains associated with:

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

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

Storage And Handling



Flammable - keep away from fire or flame.

Other information:

Store at room temperature.

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


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

Description



Made in CHINA

LOT/EXP:

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

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


Active Ingredients



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

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

Polymyxin B Sulfate 5000 units


Indications & Usage



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


Inactive Ingredient



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.


Otc - Ask Doctor



Ask a doctor before use if the user has liver disease

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

Otc - Ask Doctor/Pharmacist



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

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

Otc - Pregnancy Or Breast Feeding



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

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.

Dosage & Administration



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.

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.



General Precautions



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


Otc - When Using



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

* Please review the disclaimer below.