FDA Label for Sterile Isotonic Buffered Genuine Eyewash

View Indications, Usage & Precautions

Sterile Isotonic Buffered Genuine Eyewash Product Label

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

One Prep pad saturated with a 10% Povidone-Iodine solution equivalent to 1% available iodine

Ethyl Alcohol 62%

Active Ingredient:                                

Isopropyl Alcohol, 70% v/v

Active Ingredient:                           Purpose:

Benzocaine, 6% w/v

SD alcohol, 60% w/v


Purpose



Antiseptic

Triple Antibiotic

antiseptic, germicidal

Antimicrobial

Purpose: First aid antiseptic, external analgesic


Pain reliever/fever reducer
Analgesic/antipyretic

Pain Reliever / fever reducer 

Antiseptic

Topical AnestheticAntiseptic

Use



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

 For preparation of skin before injection.


Warnings



Warning:   For external use only.


For external use only.

For external use only.

Flammable


For external  use only



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

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

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:

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.

 For external use only.  

Warnings: For external use only.

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


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.

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, 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.

Keep out of reach of children.  If swallowed,

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 ifcondition worsenssymptoms persist for more than 7 dayscondition clears up and occurs again within a few days

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 - Do Not Use



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: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one weekDo not use: in the eyes or apply over large areas of the body.longer than 1 week unless directed by a doctor.in large quantities, particularly over raw surfaces or blistered areas.Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.When using this product, avoid contact with the eyes.
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 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.


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

Clean intended area thoroughly with pad. Discard after single use.

Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.



Adults and children 2 years of age and older

clean affected area.

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

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.


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


Wipe Injection site vigorously and discard.

Clean intended area thoroughly with pad. Discard after single use.


Inactive Ingredients



Inactive Ingredient:   Purified water


Purified water.

Propylene glycol, carbomer, titanium dioxide, purified water

Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine

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

Cornstarch, polyethylene glycol, stearic acid, povidone

hypromellose, polyethylene glycol, propylene glycol, corn starch

Purified water


Other



LOT/EXP:                           Made in CHINA

20130301

LOT/EXP:            Made in CHINA

20140301


Package Label.Principal Display Panel



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.



Triple Antibiotic Ointment 10pcs

Net wt. 0.9g (1/32oz)



100
Triple Antibiotic

AntisepticPovidone-IodinePrep Pads mediumSaturated with a 10% Povidone-IodineSolution equavalent to 1% available iodineGFA Production Xiamen Co., Ltd.www.gfaproduction.comGFA Production Xiamen Co., Ltd.No. 20 Huli Industrial Park, Meixi Road,Tong'an, Xiamen, Fujian, China 361100Wellkang Ltd t/a Wellkang Tech ConsultingSuite B, 29 Harley StreetLONDON W1G 9QR, England, United Kingdom

Genuine Hand Sanitizer

Instant Gel

Antiseptic Handwash with Vitamin E and Aloe

Kills 99.9% of germs without water

Active Ingredient:

Ethyl alcohol 62%

Net Wt 0.9g (1/32oz)

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

IBUPROFEN 2 Tablets

IBUPROFEN   2 Tablets

GENUINE FIRST AID         2 Tablets

NON-ASPIRIN

ASPIRIN 2 Tablets

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




100 Alcohol cleansing pads

Reorder GFAP-39-02

Insect Sting Relief Pad


Genuine First Aid LLC, Clearwater FL 33755
                        www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID


Active Ingredients



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

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

Polymyxin B Sulfate 5000 units

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%



Indications & Usage



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


Storage And Handling



Other information:

Store at room temperature.

Other Information:

Store at room temperature (do not freeze).

Taper evident sealed packets.

Do not use packet if opened or torn.

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


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 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.


Inactive Ingredient



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)


Purified water.


Uses



Provides, antiseptic germicidal skin preperation for minor invasive procedures

For handwashing to decrease bacteria on the skin.

First aid to help prevent infection and for the temporary relief of pain and itching associated with:

Minor Cuts

Scrapes

Burns

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


temporary relief of minor aches and pains associated with:

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

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


Keep Out Of Reach Of Children



For external use only.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.


Caution



In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.


Do Not Use



in the eyes. In case of contact, rinse eyes thoroughly with water.

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

 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


Stop Use And Consult A Doctor



If irritation and redness develop and persist for more than 72 hours

Description



LOT/EXP:                                    Made in CHINA

20130301



GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

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

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

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

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:


Made in CHINA

LOT/EXP:


Active Ingredient (In Each Tablet)



Ibuprofen USP (NSAID*) 200mg
*nonsteroidal anti-inflammatory drug

Acetaminophen 325 mg

  Aspirin (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug 


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 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic


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

When Using This Product



Take with food or milk if stomach upset 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
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

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.

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.


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

Otc - Ask Doctor/Pharmacist



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

Ask a doctor or pharmacist before use if you are:

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


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.

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.

DirectionsRemove contacts before using.Twist top to remove.Flush the affected area as needed. ControlRate of flow by pressure on the bottle. Do not touchtip of the container to any surface. Do not reuse.If necessary continue flushing with emergency eyewash or shower.Discard bottle after use.

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


Otc - Active Ingredient



Active Ingredient:

Purified Water USP...q.s.


Otc - Purpose



Uses:For flushing or irrigating the eyes toremove loose foreign material, air pollutants, or chlorinated water.

* Please review the disclaimer below.