FDA Label for Sterile Isotonic Buffered Genuine Eyewash
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - STOP USE
- OTC - DO NOT USE
- DIRECTIONS
- INACTIVE INGREDIENTS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENTS
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- USES
- KEEP OUT OF REACH OF CHILDREN
- CAUTION
- DO NOT USE
- STOP USE AND CONSULT A DOCTOR
- DESCRIPTION
- ACTIVE INGREDIENT (IN EACH TABLET)
- OTC - ASK DOCTOR
- ASK A DOCTOR BEFORE USE IF YOU ARE:
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTHER INFORMATION
- OTC - ASK DOCTOR/PHARMACIST
- DOSAGE & ADMINISTRATION
- GENERAL PRECAUTIONS
- OTC - WHEN USING
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
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
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
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 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 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 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
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
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
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
10ml
Sterile Isotonic Buffered Genuine
Eyewash
For single use only
Alcohol Cleansing Pad
Genuine First Aid LLC, Clearwater FL 33755www.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 111mgEdetate 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 fevertemporary 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 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.
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.