FDA Label for 25 Person Ansi

View Indications, Usage & Precautions

25 Person Ansi 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 INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Active Ingredient:                                            Purpose

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

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

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

Polymyxin B Sulfate 5000 units

Active Ingredient:

Purified Water USP...q.s.

Active Ingredient:                                    Purpose:

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

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

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

Active Ingredient (in each tablet)                             Purpose

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

*nonsteroidal anti-inflammatory drug  

Active Ingredient:                                        Purpose

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

Active Ingredient:

Ethyl Alcohol 62 percent

Genuine Hand Sanitizer

Instant Gel

Antiseptic Handwash

with Vitamin E and Aloe

Kills 99.9 percent of germs

Without Water

Active Ingredient:
Ethyl Alcohol 62 percent

Net Wt 0.9g (1/32 oz)

Manufactured in China For

Genuine First Aid.


Otc - Purpose



Purpose: First aid antiseptic, external analgesic

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

Minor Cuts

Scrapes

Burns

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

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

Uses:

For flushing or irrigating the eyes to

remove loose foreign material, air pollutants,

or chlorinated water.

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


Uses temporarily relieves minor aches and pains due to:

the common cold

headache

toothache

muscular aches

backache

minor pain of arthritis

menstrual cramps temporarily reduces fever

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

Use:    For preparation of skin before injection.

Enter section text here


Warnings



Warnings:

For external  use only

Warning:    For external use only.

Warnings:

For external use only.

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.

Warnings: For external use only.

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

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.

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

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

Warnings:    For external use only. 

Warnings:

For external use only

Flammable, keep away from fire or flame


Otc - Do Not Use



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 week

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, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.


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 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; if you are taking a prescription drug for gout, diabetes or arthritis

Do not use: with electrocautery, in the eyes.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.


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:  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 swallowed, 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.  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.

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


Dosage & Administration



Directions: Clean affected area, Apply small amount not more than 3 times daily.

May be covered with a sterile bandage.


Directions

Remove contacts before using.

Twist top to remove.

Flush the affected area as needed. Control

Rate of flow by pressure on the bottle. Do not touch

tip of the container to any surface. Do not reuse.

If necessary continue flushing with emergency eyewash or shower.

Discard bottle after use.

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.

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.

Directions:

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


Storage And Handling



Other Information:

Store at room temperature

Other information:

Store at room temperature.

Store in a cool place. For irrigation only.

Discard unused portion of the solution.

Not for injection.

Flammable - keep away from fire or flame.


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 Farenheat (15-30 degree Celcius)

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

Flammable - keep away from fire or flame

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

Other Information: Store at 15 to 25 degree Celsius  (59 to 77 degree Fahrenheit)


Package Label.Principal Display Panel



Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

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.

10ml

Sterile Isotonic Buffered Genuine

 Eyewash

For single use only

Insect Sting Relief Pad

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

1/pouch

GENUINE FIRST AID

IBUPROFEN 2 Tablets

GENUINE FIRST AID            2 Tablets

NON-ASPIRIN

ASPIRIN 2 Tablets

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

ANSI/ISEA Z308.1-2009 TYPE III

Caution! This Kit meets ANSI/ISEA Z308.1-2009 only when required minimum fill is maintained with first aid products marked "ANSI/ISEA Z308.1-2009."


CARRYING CASE
1 Easy Access Pocket System
1 Hard Case

POCKET1: SMALL CUTS AND BURNS
50 Adhesive Plastic Bandages 1"x3"
1 Knuckle Fabric Bandage
25Adhesive Spot Bandages 7/8"X7/8"
1Fingertrip Fabric Bandage
1 Elbow Knee Adhesive Bandage
6 Burn Cream
10Antiseptic Towelettes
6 Triple Antibiotic Ointment 0.5gr
20 Cotton Tipped Applicators

POCKET 2: MEDIUM CUTS AND SCRATCHES
10 Antiseptic Towelettes
4 Sterile Gauze Pad 3"x3"
2 Sterile Gauze Pads 4"X4"
2 Roller Gauze Bandage 2"X4.1yds
1 Roller Gauze Bandage 3"X4.1yds
1 Sterile Eye Pads
1 Sterile Eye Wash 10ml Twist Top
1 Butterfly Wound Closure, Medium

POCKET 3: SEVERE BLEEDING AND BURNS
1 First Aid Tape Roll 1/2"x5 yds.
1 Combine Pad 5"X9"

POCKET 4: CPR
1 CPR Breathing Barrier

POCKET 5: PROTECTION
4 Medical Grade Vinyl Gloves
1 Instant Cold Compress
20 Alcohol Cleansing Pads
1 Hand Sanitizer 0.9g
1 Insect Sting Relief Pads
1 Triangular Bandage 42"x42"x59"
2 Ibuprofen 200mg
2Non Aspirin 325mg
2 Aspirin 325mg

POCKET 6: INSTRUMENTS
1 Emergency First Aid Guide
1 Plastic Tweezers
1 Scissors



Manufactured in China for:

Genuine First Aid LLC.
600 Cleveland Street
Suite 400
Clearwater FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID

Copyright c 2010 Genuine First Aid LLC. All rights reserved.


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

Stop use and consult a doctor if irritation and redness develop

and persist for more than 72 hours.


Otc - When Using



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

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

Wipe Injection site vigorously and discard.


Inactive Ingredient



Inactive Ingredient:    Purified 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)

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.


Description



LOT/EXP:                                    Made in CHINA

20130301

Code No.: GUJ/DRUG/G/1080

Batch No.:

Mfg Date:

Exp: Date:

Made in CHINA

LOT/EXP:

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

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

20140301


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


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 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


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.


General Precautions



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


* Please review the disclaimer below.