GFA FIRST AID- benzalkonium chloride, benzalkonium chloride, lidocaine, povidone-iodine, bacitracin zinc, neomycin sulfate, polymyxin b kit

GFA First Aid by

Drug Labeling and Warnings

GFA 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:                        

Benzalkonium Chloride 0.40%

Purpose

Antiseptic

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.

Directions

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

Inactive Ingredients

Inactive Ingredient:   Purified water

SPL UNCLASSIFIED SECTION

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 Ingredients

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

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

Do not use:
in the eyes or apply over large areas of the body.
longer than 1 week unless directed by a doctor.
in large quantities, particularly over raw surfaces or blistered areas.

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.

When using this product, avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days
condition clears up and occurs again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children.

If ingested, contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

clean affected area.

apply a small amount of this product on the area 1 to 3 times daily.

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

STORAGE AND HANDLING

Other Information:

Store at room temperature (do not freeze).

Taper evident sealed packets.

Do not use packet if opened or torn.

Inactive Ingredients

Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine

DESCRIPTION

LOT/EXP:                                    Made in CHINA

20130301

GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100
Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

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Genuine First Aid Burn Cream

Antiseptic Pain Relief With Aloe

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for

Genuine First Aid.

Active Ingredients

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

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

Polymyxin B Sulfate 5000 units

Purpose

Triple Antibiotic

INDICATIONS & USAGE

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

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.

Directions

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.

Inactive Ingredient

water

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.

Triple Antibiotic Ointment 10pcs

Net wt. 0.9g (1/32oz)

100
Triple Antibiotic

Active Ingredient

One Prep pad saturated with a 10% Povidone-Iodine solution equivalent to 1% available iodine

Purpose

antiseptic, germicidal

Uses

Provides, antiseptic germicidal skin preperation for minor invasive procedures

Keep out of reach of children

For external use only.

Caution

In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.

Inactive Ingredients

Purified water.

Directions

Clean intended area thoroughly with pad. Discard after single use.

PRINCIPAL DISPLAY PANEL

Antiseptic
Povidone-Iodine
Prep Pads
 medium
Saturated with a 10% Povidone-Iodine
Solution equavalent to 1% available iodine

GFA Production Xiamen Co., Ltd.
www.gfaproduction.com

GFA Production Xiamen Co., Ltd.
No. 20 Huli Industrial Park, Meixi Road,
Tong'an, Xiamen, Fujian, China 361100

Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street
LONDON W1G 9QR, England, United Kingdom

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INGREDIENTS AND APPEARANCE

GFA FIRST AID  24 UNIT METAL CASE
benzalkonium chloride, benzalkonium chloride, lidocaine, povidone-iodine, bacitracin zinc, neomycin sulfate, polymyxin b kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-1166

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-1166-4	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	10 PACKET	8.0 mL
Part 2	6 PACKET	5.4 g
Part 3	10 TUBE	5.0 g
Part 4	10 PACKET	5 mL

Part 1 of 4

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	0.4 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: 52124-0001-2	10 in 1 BOX
1		0.8 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/03/2011

Part 2 of 4

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0004-2	6 in 1 BOX
1		0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	04/13/2011

Part 3 of 4

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: 52124-0003-2	10 in 1 BOX
1		0.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/13/2011

Part 4 of 4

POVIDONE-IODINE PREP 
povidone-iodine swab

Product Information
Item Code (Source)	NDC: 52124-2901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 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: 52124-2901-1	10 in 1 BOX
1		0.5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333E	05/03/2011

Labeler - Genuine First Aid, LLC (619609857)