Label: AUTO 157 - benzalkonium chloride, lidocaine, benzocaine, alcohol, ibuprofen, acetaminophen, aspirin

  • NDC Code(s): 52124-0001-1, 52124-0004-1, 52124-0008-1, 52124-0009-1, view more
    52124-0010-1, 52124-0011-1, 52124-0118-1
  • Packager: Genuine First Aid LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 7, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Benzalkonium Chloride 0.13%
    Lidocaine HCL 0.5%

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  • 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

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  • WARNINGS

    Warnings:

    For external  use only

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children.

    If ingested, contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

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

    May be covered with a sterile bandage.

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  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature

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  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301

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  • 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.

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  • ACTIVE INGREDIENT

    Active Ingredient:                                            Purpose

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

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  • PURPOSE

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

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  • WARNINGS

    Warning:    For external use only.

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  • 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.

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  • STOP USE

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

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  • DO NOT USE

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

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  • WHEN USING

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

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  • INACTIVE INGREDIENT

    Inactive Ingredient:    Purified water

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  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301

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  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

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  • ACTIVE INGREDIENT

    Active Ingredient:                                    Purpose:

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

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

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  • PURPOSE

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

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  • WARNINGS

    Warnings: For external use only.

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

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  • 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.

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  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame.

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  • DO NOT USE

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

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  • DESCRIPTION

    Made in CHINA

    LOT/EXP:

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  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad

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

    1/pouch

    GENUINE FIRST AID

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)                       Purpose

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

    *nonsteroidal anti-inflammatory drug

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  • 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

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  • WARNINGS

    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

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  • DO NOT USE

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

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  • 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

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  • 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

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  • WHEN USING

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

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  • STOP USE

    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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    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.

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  • STORAGE AND HANDLING

    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

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  • INACTIVE INGREDIENT

    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.

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  • DESCRIPTION

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

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  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN 2 Tablets

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                Purpose

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

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  • 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

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  • WARNINGS

    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

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  • DO NOT USE

    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

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  • ASK DOCTOR

    Ask a doctor before use if the user has liver disease

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  • ASK DOCTOR/PHARMACIST

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

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  • STOP USE

    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

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    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

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  • 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.

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  • STORAGE AND HANDLING

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

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  • GENERAL PRECAUTIONS

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

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  • DESCRIPTION

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

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  • PRINCIPAL DISPLAY PANEL

    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  

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  • 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

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  • WARNINGS

    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

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  • DO NOT USE

    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

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

    Close
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:

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

    Close
  • WHEN USING

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

    Close
  • STOP USE

    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

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  • PREGNANCY OR BREAST FEEDING

    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.

    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    contact a Poison Control Center right away.

    Close
  • WHEN USING

    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

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  • DOSAGE & ADMINISTRATION

    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.

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  • STORAGE AND HANDLING

    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

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  • INACTIVE INGREDIENT

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

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  • DESCRIPTION

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

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  • PRINCIPAL DISPLAY PANEL

    ASPIRIN 2 Tablets

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  • PRINCIPAL DISPLAY PANEL

    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

     2 Imperdibles ( alfileres de gancho )

    Genuine First Aid LLC

    814471010167

    Copyright c 2010 Genuine First Aid LLC.

    All rights reserved.

    Manufactured in China for:

    Genuine First Aid LLC.

    600 Cleveland Street

    Suite 400

    Clearwater, FL 33755

    www.GenuineFirstAid.com

    GENUINE FIRST AID.

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  • INGREDIENTS AND APPEARANCE
    AUTO 157 
    benzalkonium chloride, lidocaine, benzocaine, alcohol, ibuprofen, acetaminophen, aspirin kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0118
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0118-1 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 3 PACKAGE 2.7 g
    Part 2 12 PACKAGE 9.6 mL
    Part 3 2 PACKAGE 1 mL
    Part 4 2 PACKAGE
    Part 5 2 PACKAGE
    Part 6 1 PACKAGE
    Part 1 of 6
    GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Item Code (Source) NDC:52124-0004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.5 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0004-1 0.9 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part345 05/07/2010
    Part 2 of 6
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:52124-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 05/08/2010
    Part 3 of 6
    INSECT STING RELIEF PAD 
    benzocaine,alcohol liquid
    Product Information
    Item Code (Source) NDC:52124-0008
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0008-1 0.5 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 05/08/2010
    Part 4 of 6
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Item Code (Source) NDC:52124-0009
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (White) Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0009-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075010 05/08/2010
    Part 5 of 6
    NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source) NDC:52124-0010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white (WHITE) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code AZ;234
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0010-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/08/2010
    Part 6 of 6
    ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source) NDC:52124-0011
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (White) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;157;ASPIRIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0011-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 05/08/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 05/07/2010
    Labeler - Genuine First Aid LLC (619609857)
    Establishment
    Name Address ID/FEI Business Operations
    GFA Production ( Xiamen) Co., Ltd 421256261 manufacture
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