Genuine First Aid - Auto First Aid

Dosage form: kit
Ingredients: BACITRACIN ZINC 400[iU] in 1g, NEOMYCIN SULFATE 5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g; IBUPROFEN 200mg; ACETAMINOPHEN 500mg; BENZALKONIUM CHLORIDE 0.40mL in 100mL; ISOPROPYL ALCOHOL 70mL in 100mL
Labeler: Genuine First Aid, LLC
NDC Code: 52124-1000

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.

Genuine First Aid Auto First Aid Kit

Active Ingredient:                                        Purpose

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

Use:    For preparation of skin before injection.

Warnings:    For external use only.

Flammable - keep away from fire or flame

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

Do not use: with electrocautery, in the eyes.

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

Keep out of reach of children.  If swallowed,

get medical help or contact a Poison Control

Center right away.

Wipe Injection site vigorously and discard.

Inactive Ingredient:    Purified water.

LOT/EXP:                Made in CHINA

20140301

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

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

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

Polymyxin B Sulfate 5000 units

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

Warnings:

For external use only.

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.

Stop use and consult a doctor:

if the condition persists or gets worse;  a rash or other allergic reaction develops

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

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

Other information:

Store at room temperature.

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.


Active ingredient (in each tablet)                       Purpose

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

*nonsteroidal anti-inflammatory drug


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

IBUPROFEN   2 Tablets

Active Ingredient (in each tablet)                      Purpose

Acetaminophen 500 mg...............................   Pain Reliever / fever reducer


Purpose: Pain reliever, fever reducer

Uses   for the temporary relief of minor aches and pains associated with
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

Warnings

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

Do not use:  with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
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 you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swellign is present

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

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

Adults and children: (12 years and older)
take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:
do not give to children under 12 years of age.

Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

Active Ingredient:                                 Purpose

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

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

GENUINE FIRST AID - AUTO FIRST AID 
benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-1000
Packaging
#Item CodePackage Description
1NDC:52124-1000-11 KIT (KIT) in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 0.5 g
Part 21 PACKET
Part 31 PACKET
Part 42 PACKAGE 1.6 mL
Part 52 PACKAGE 1 mL
Part 1 of 5
GENUINE TRIPLE ANTIBIOTIC 
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:52124-0003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0003-1.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/11/2011
Part 2 of 5
IBUPROFEN 
ibuprofen tablet
Product Information
Item Code (Source)NDC:52124-0009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE 
STARCH, CORN 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;352
Contains    
Packaging
#Item CodePackage Description
1NDC:52124-0009-12 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07501001/11/2011
Part 3 of 5
MEDIQUE APAP EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Item Code (Source)NDC:47682-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 
POVIDONE 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUNDSize12mm
FlavorImprint CodeAZ;235
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-175-462 TABLET, FILM COATED (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/11/2011
Part 4 of 5
ANTISEPTIC TOWELETTE 
benzalkonium chloride swab
Product Information
Item Code (Source)NDC:52124-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.40 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0001-10.8 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E01/11/2011
Part 5 of 5
ALCOHOL CLEANSING PAD 
isopropyl alcohol liquid
Product Information
Item Code (Source)NDC:52124-0002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:52124-0002-10.5 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/11/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/11/2011
Labeler - Genuine First Aid, LLC (619609857)

Revised: 01/2011
 
Genuine First Aid, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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