Standard Ansi First Aid (Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride) Kit [Gfa Production (Xiamen) Co., Lt -

STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LT
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NDC	50814-010-01, 50814-011-01, 50814-012-01, 50814-013-01, 50814-014-01, 50814-015-01, 50814-020-01
Set ID	94dd796a-d589-4744-b11a-acc8ef4b346f
Category	HUMAN OTC DRUG LABEL
Packager	GFA Production (Xiamen) Co., Ltd.
Generic Name
Product Class	Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number	PART333B

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Drug Facts
Active ingredient

Purified Water 99.1%

Purpose

Eyewash
Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material
Warnings

For external use only.

Do not use

if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Stop use and ask a doctor if

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
Other information

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)
Inactive ingredients

Benzalkonium chloride, sodium chloride
DRUG FACTS
Active Ingredient:

Benzalkonium Chloride 0.13%

Purpose:

First Aid Antiseptic
Use:

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Warnings:

For external use only.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 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.
DRUG FACTS
Active Ingredient:

Isopropyl Alcohol, 70% v/v

Purpose:

Antiseptic
Use:

For preparation of the skin before injection.
Warnings:

For external use only.

Flammable - keep away from fire or flame.

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.
Directions:

Wipe injection site vigorously and discard.
Other information:

Store at room temperature 15°-30° C (59°-86° F)
Inactive ingredient:

Purified water.
Drug Facts

Drug Facts
Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic
Use
- First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings

For external use only.

Do not use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

Stop use and ask a doctor if

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions

• Clean the affected area. • Apply a 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 ingredients

Mineral oil, petrolatum, purified water
Drug Facts
Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream
Uses
- First aid to help prevent infection in minor cuts, scrapes, and burns.
- For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Warnings

For external use only.

Do not use

• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
- Children under 2 years of age: consult a doctor
- May be covered with a sterile bandage
Other information

Store at room temperature
Inactive ingredients

glycerin monostearate, glycerol, purified water
Drug Facts
Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic
Uses
- For handwashing to decrease bacteria on the skin
- Recommended for repeated use.
Warnings
Flammable, keep away from fire or flame

For external use only.

Do not use

in the eyes.
Stop use and ask a doctor if
- irritation and redness develop
- condition persists for more than 72 hours
Keep out of reach children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wet hands thoroughly with product and allow to dry without wi
Other information

Store at 15° to 25°C (59° to 77°F)
Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide
Eye Wash (50814-010-01) Labeling:
Antiseptic Towelettes (50814-011-01) Labeling:
Alcohol Cleansing Pads (50814-012-01) Labeling:
Antibiotic Application (50814-013-01) Labeling:
Burn Treatment (50814-014-01) Labeling:
Hand Sanitizer (50814-015-01) Labeling:
Standard ANSI First Aid (50814-020-01) Labeling:

INGREDIENTS AND APPEARANCE

STANDARD ANSI FIRST AID
water, benzalkonium chloride, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50814-020

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50814-020-01	1 in 1 KIT	08/10/2016

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	30 mL
Part 2	10 PATCH	9 g
Part 3	10 PATCH	9 g
Part 4	6 PACKAGE	5 g
Part 5	10 PACKAGE	9 g
Part 6	6 PACKAGE	5.4 g

Part 1 of 6

EYE WASH
water solution

Product Information
Item Code (Source)	NDC:50814-010
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	991 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description
Packaging
1	NDC:50814-010-01	1 in 1 BOX
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part349	08/10/2016

Part 2 of 6

ANTISEPTIC TOWELETTES
benzalkonium chloride cloth

Product Information
Item Code (Source)	NDC:50814-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

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

#	Item Code	Package Description
Packaging
1	NDC:50814-011-01	1 in 1 BOX
1		10 in 1 BOX
1		0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/10/2016

Part 3 of 6

ALCOHOL CLEANSING
isopropyl alcohol cloth

Product Information
Item Code (Source)	NDC:50814-012
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 g in 100 g

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

#	Item Code	Package Description
Packaging
1	NDC:50814-012-01	1 in 1 BOX
1		10 in 1 BOX
1		0.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/10/2016

Part 4 of 6

ANTIBIOTIC APPLICATION
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC:50814-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:50814-013-01	1 in 1 BOX
1		10 in 1 BOX
1		0.9 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	08/10/2016

Part 5 of 6

BURN TREATMENT
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Item Code (Source)	NDC:50814-014
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:50814-014-01	1 in 1 BOX
1		10 in 1 BOX
1		0.9 g in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/10/2016

Part 6 of 6

HAND SANITIZER
alcohol gel

Product Information
Item Code (Source)	NDC:50814-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description
Packaging
1	NDC:50814-015-01	1 in 1 BOX
1		6 in 1 BOX
1		0.9 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	08/10/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture(50814-020, 50814-010, 50814-011, 50814-012, 50814-013, 50814-014, 50814-015)

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Medic

STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LT

Purpose

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Purpose:

Keep out of reach of children.

Do not use:

Purpose:

Do not use:

Stop use

Keep out of reach of children.

Purpose

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

Purpose

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reah of children.

Purpose

Do not use

Stop use and ask a doctor if

Keep out of reach children.

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