GFA FIRST AID KIT ESSENTIALS - 33 PIECES- aspirin, ibuprofen, acetaminophen, alcohol, benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Drug Details [pdf]

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

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

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

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 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
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
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 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
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.
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.
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
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.
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
INACTIVE INGREDIENT

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

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

ASPIRIN 2 Tablets
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
Active Ingredient (in each tablet)

Acetaminophen 325 mg
Purpose

Analgesic/antipyretic
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 DOCTOR

Ask a doctor before use if the user has liver disease
ASK DOCTOR/PHARMACIST

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

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

Cornstarch, polyethylene glycol, stearic acid, povidone
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.
STORAGE AND HANDLING

Store at 59-86 degree F (15-30 degree C)
GENERAL PRECAUTIONS

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

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

GENUINE FIRST AID 2 Tablets

NON-ASPIRIN
Active Ingredient

Active Ingredient:

Isopropyl Alcohol, 70% v/v
Purpose

Antiseptic
Use

For preparation of skin before injection.
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.
Directions

Wipe Injection site vigorously and discard.
Inactive Ingredient

Purified water.
SPL UNCLASSIFIED SECTION

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

100 Alcohol cleansing pads

Reorder GFAP-39-02
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
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PRINCIPAL DISPLAY PANEL

GFA FIRST AID KIT ESSENTIALS - 33 PIECES
aspirin, ibuprofen, acetaminophen, alcohol, benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-1023

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-1023-6	1 in 1 KIT

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 TUBE	1 g
Part 2	2 PACKET	4
Part 3	2 PACKAGE	4
Part 4	3 PACKAGE	1.5 mL
Part 5	2 PACKAGE	4
Part 6	3 PACKAGE	2.4 mL

Part 1 of 6

GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 52124-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	08/18/2011

Part 2 of 6

IBUPROFEN
ibuprofen tablet

Product Information
Item Code (Source)	NDC: 52124-0009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-0009-1	2 in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075010	08/18/2011

Part 3 of 6

NON-ASPIRIN
acetaminophen tablet

Product Information
Item Code (Source)	NDC: 52124-0010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-0010-1	2 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	08/18/2011

Part 4 of 6

ALCOHOL CLEANSING PAD
isopropyl alcohol liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-0002-1	0.5 mL in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/18/2011

Part 5 of 6

ASPIRIN
aspirin tablet

Product Information
Item Code (Source)	NDC: 52124-0011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-0011-1	2 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	08/18/2011

Part 6 of 6

ANTISEPTIC TOWELETTE
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC: 52124-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.40 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52124-0001-1	0.8 mL in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333E	09/09/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333B	08/18/2011

Labeler - Genuine First Aid, LLC (619609857)

Registrant - GFA Production (Xiamen) Co., Ltd. (421256261)

Name	Address	ID/FEI	Business Operations
Establishment
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture

GFA FIRST AID KIT ESSENTIALS - 33 PIECES- aspirin, ibuprofen, acetaminophen, alcohol, benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

GFA First Aid Kit Essentials - 33 Pieces by

Drug Labeling and Warnings

Drug Details [pdf]