GFA First Aid 36 Unit Metal Case: Package Insert and Label Information

GFA FIRST AID 36 UNIT METAL CASE- benzalkonium chloride, benzalkonium chloride, lidocaine, povidone-iodine, bacitracin zinc, neomycin sulfate, polymyxin b
Genuine First Aid, LLC

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.

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: 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 Ingredients

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

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: 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 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.
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

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

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

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

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

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.

Inactive Ingredient

water

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.


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

Povidone-Iodine Prep Pads
(click image for full-size original)

Povidone-Iodine Prep Pads
(click image for full-size original)

Genuine Triple Antibiotic
(click image for full-size original)

Genuine Triple Antibiotic
(click image for full-size original)

Burn Cream
(click image for full-size original)

Burn Cream
(click image for full-size original)

Antiseptic Towelette
(click image for full-size original)

Antiseptic Towelette
(click image for full-size original)

GFA First Aid Kit
(click image for full-size original)

GFA First Aid Kit
(click image for full-size original)

GFA FIRST AID 36 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:52124-1167
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-1167-4 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 20 PACKET 16.0 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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.4 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0001-2 10 PACKET (PACKET) in 1 BOX contains a PACKET
1 0.8 mL in 1 PACKET This package is contained within the BOX (52124-0001-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/04/2011
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 0.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CETYL ALCOHOL
DIAZOLIDINYL UREA
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
METHYLPARABEN
MINERAL OIL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
STEARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0004-2 6 PACKET (PACKET) in 1 BOX contains a PACKET
1 0.9 g in 1 PACKET This package is contained within the BOX (52124-0004-2)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 400 [iU] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0003-2 10 TUBE (TUBE) in 1 BOX contains a TUBE
1 0.5 g in 1 TUBE This package is contained within the BOX (52124-0003-2)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-2901-1 10 PACKET (PACKET) in 1 BOX contains a PACKET
1 0.5 mL in 1 PACKET This package is contained within the BOX (52124-2901-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/04/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333E 05/04/2011
Labeler — Genuine First Aid, LLC (619609857)

Revised: 05/2011 Genuine First Aid, LLC

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