GENUINE FIRST AID - HOME FIRST AID- benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen kit

Genuine First Aid - Home First Aid by

Drug Labeling and Warnings

Genuine First Aid - Home First Aid by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                                        Purpose

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

PURPOSE

Use:    For preparation of skin before injection.

WARNINGS

Warnings:    For external use only.

STORAGE AND HANDLING

Flammable - keep away from fire or flame

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

DO NOT USE

Do not use: with electrocautery, in the eyes.

STOP USE

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

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.

WHEN USING

Wipe Injection site vigorously and discard.

INACTIVE INGREDIENT

Inactive Ingredient:    Purified water.

DESCRIPTION

LOT/EXP:                Made in CHINA

20140301

PRINCIPAL DISPLAY PANEL

Alcohol Cleansing  Pad
Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

ACTIVE INGREDIENT

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

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

Polymyxin B Sulfate 5000 units

PURPOSE

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

WARNINGS

Warnings:

For external use only.

DO NOT USE

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

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

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

WHEN USING

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

STORAGE AND HANDLING

Other information:

Store at room temperature.

PRINCIPAL DISPLAY PANEL

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

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

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

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 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 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

WHEN USING

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

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

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.

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.

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.

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

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.

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

IBUPROFEN 2 Tablets

PRINCIPAL DISPLAY PANEL

IBUPROFEN   2 Tablets

ACTIVE INGREDIENT

Active Ingredient (in each tablet)                      Purpose

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

PURPOSE

Purpose: Pain reliever, fever reducer

INDICATIONS & USAGE

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

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

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 DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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 INGREDIENT

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

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.

WARNINGS

Warning:   For external use only.

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.

STOP USE

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

DO NOT USE

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

WHEN USING

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

INACTIVE INGREDIENT

Inactive Ingredient:   Purified water

DESCRIPTION

LOT/EXP:                           Made in CHINA

20130301

PRINCIPAL DISPLAY PANEL

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENUINE FIRST AID - HOME FIRST AID 
benzalkonium chloride, ibuprofen, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-1200

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-1200-1	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	0.5 g
Part 2	1 PACKET	2
Part 3	1 PACKET	2
Part 4	2 PACKAGE	1.6 mL
Part 5	2 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B SULFATE	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0003-1	.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/11/2011

Part 2 of 5

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)
HYPROMELLOSES (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 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075010	01/11/2011

Part 3 of 5

MEDIQUE APAP EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Item Code (Source)	NDC: 47682-175
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-175-46	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/11/2011

Part 4 of 5

ANTISEPTIC TOWELETTE 
benzalkonium chloride swab

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	part333E	01/11/2011

Part 5 of 5

ALCOHOL CLEANSING PAD 
isopropyl alcohol liquid

Product Information
Item Code (Source)	NDC: 52124-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 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: 52124-0002-1	0.5 mL in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/11/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/11/2011

Labeler - Genuine First Aid, LLC (619609857)