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Auto 157

Genuine First Aid LLC

Auto 157




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS:

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

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

Warnings:

For external  use only

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

Keep out of reach of Children.

If ingested, contact a Poison Control Center right away.

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

May be covered with a sterile bandage.

Other Information:

Store at room temperature

LOT/EXP:                                    Made in CHINA

20130301

Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

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Active ingredient

Active Ingredient:                                            Purpose

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

Purpose

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

Warning:    For external use only.

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

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

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

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

Inactive Ingredient:    Purified water

LOT/EXP:                                    Made in CHINA

20130301

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Auto 157

Active ingredient

Active Ingredient:                                    Purpose:

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

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

Purpose

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

Warnings: For external use only.

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

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

Flammable - keep away from fire or flame.

Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

Made in CHINA

LOT/EXP:

Insect Sting Relief Pad

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

1/pouch

GENUINE FIRST AID

Auto 157

Active ingredient

Active ingredient (in each tablet)                       Purpose

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

*nonsteroidal anti-inflammatory drug

Purpose

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

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

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

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 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

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.

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

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.

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

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.

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

IBUPROFEN 2 Tablets

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Active ingredient

Active Ingredient (in each tablet)                Purpose

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

Purpose

Uses

temporary relief of minor aches and pains associated with:

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

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

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

Ask a doctor before use if the user has liver disease

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

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

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

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

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.

Store at 59-86 degree Fahrenheit (15-30 degree Celcius)

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

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

GENUINE FIRST AID            2 Tablets

NON-ASPIRIN

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Active ingredient

Active Ingredient (in each tablet)                             Purpose

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

*nonsteroidal anti-inflammatory drug  

Purpose

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

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

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

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 or pharmacist before use if you are:

under a doctor's care for any serious condition;  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 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

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.

Keep out of reach of children.  In case of overdose, get medical help or

contact a Poison Control Center right away.

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

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.

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

Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

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

ASPIRIN 2 Tablets

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CARRYING CASE

1 Hard Case

1 Easy Access Pocket System

POCKET 1: SMALL CUTS and BURNS

50 Adhesive Plastic Bandages 3/4" X 3"

40 Junior Adhesive Plastic Bandages 3/8" X 1-1/2"

 2 Knuckle Fabric Bandages

 1 Adhesive Spot Bandages 7/8"X7/8"

 1 Fingertip Fabric Bandage

 3 Burn Cream

12 Antiseptic Towelettes

10 Cotton Tipped Applicators

POCKET 2: MEDIUM CUTS and SCRATCHES

 6 Sterile Gauze Pads 2"X2"

 2 Sterile Gauze Pads 3"X3"

 1 Roller Gauze Bandage 2" X 4.1yds.

POCKET 3: SEVERE BLEEDING and BURNS

 1 First Aid Tape Roll 1/2" X 5yds.

 1 Combine Pad 5" X 9"

POCKET 4: CPR

 1 CPR Breathing Barrier

POCKET 5: PROTECTION

 2 Medical Grade Vinyl Gloves

 1 Instant Cold Compress

 1 Emergency Blanket 38" X 60"

 2 Insect Sting Relief Pads

 1 Triangular Bandage 42" X 42" X 59"

 4 Ibuprofen 200mg

 4 Non Aspirin 325mg

 2 Aspirin 325mg

POCKET 6: INSTRUMENTS

 1 Emergency First Aid Guide

 2 Assorted Safety Pins

-------------------------------------------------------------------------

ESTUCHE PORTATIL

 1 Estuche de Plastico

 1 Sistema de fundas para rapido acceso

FUNDA 1: CORTADURAS Y QUEMADURAS MENORES

50 Vendas Adhesivas Plasticas 3/4" X 3"

40 Vendas Plasticas Tamano Junior 3/8" X 1-1/2"

 2 Vendas de Tela para Nudillos

 5 Vendas Adhesivas Redondas 7/8"X7/8"

 1 Vendas de tela para yema del dedo

 3 Cream para Quemaduras

12 Toallitas Antisepticas

10 Aplicadores con Puntas de Algodon

FUNDA 2: CORTADURAS Y RASGUNOS MEDIANOS

 6 Almohadillas Esteril de Gasa 2"X2"

 2 Almohadillas Esteril de Gasa 3"X3"

 1 Vendas de Gasa en Rollo 2" X 4.1yds.

FUNDA 3: SANGRADO SEVERO Y QUEMADURAS

 1 Cinta de papel para Primeros Auxilios 1/2" X 5yds.

 1 Almohadilla de Uso Combinado 5" X 9"

FUNDA 4: CPR

 1 Mascarilla CPR

FUNDA 5: PROTECCION

 2 Guantes de Vinilo

 1 Compresa de Frio Instantaneo

 1 Manta Termica 38" X 60"

 2 Toallitas para Picaduras de Insectos

 1 Vendajes Triangulares 42" X 42" X 59"

 4 Ibuprofen 200mg

 4 Non Aspirin 325mg

 2 Aspirin 325mg 325mg

FUNDA 6: INSTRUMENTOS

 1 Manual de Primeros Auxilios
















Suite 400

Clearwater, FL 33755

www.GenuineFirstAid.com

GENUINE FIRST AID.

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Auto 157

BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52124-0118
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52124-0118-1 1 in 1 KIT

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part333 2010-05-07


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