FAK LARGE OFFICE FIRST AID KIT- benzalkonium chloride 
GFA Production (Xiamen) Co., Ltd.

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.

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FAK Large Office First Aid kit

Antiseptic Towelettes - 113408 10 count (50814-011-01 )
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.

Antiseptic Towelette (50814-002-01)
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.

Burn Treatment – 113402 10 count (50814-014-01)
Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

First aid antiseptic

Pain relieving cream

Uses

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

Other information

Store at room temperature

Inactive ingredients

glycerin monostearate, glycerol, purified water

Alcohol Cleansing Pads - 113409, 20 count (50814-012-01)
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.

Antibiotic Application - 113401 10 count (50814-013-01)
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

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

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

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

Hand Sanitizer – 117534 6 count (50814-015-01)
Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

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

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Eyewash - 117445 30ml (50814-010-01)
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

Eyewash 30ml (70897-002-03)
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

Package Labeling:

KitKit2

Antiseptic Towelettes

Antiseptic Towelettes

Antiseptic Towelette

Antiseptic Towelette

Burn Treatment 

Burn Treatment

Alcohol Cleansing

Alcohol Cleansing

Antibiotic Application

Antibiotic Application

Hand Sanitizer

Hand Sanitizer

Eyewash

Eyewash

Eyewash2

Eyewash2

FAK LARGE OFFICE FIRST AID KIT 
benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-031
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-031-011 in 1 KIT02/08/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PATCH 1.8 g
Part 21 BAG 4.5 g
Part 31 PACKAGE 0.9 g
Part 41 PATCH 0.9 g
Part 51 PACKAGE 0.9 g
Part 61 PACKAGE 0.9 g
Part 71 TUBE 30 mL
Part 1 of 7
ANTISEPTIC TOWELETTES 
benzalkonium chloride cloth
Product Information
Item Code (Source)NDC:50814-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-011-0110 in 1 BOX
11.8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/08/2018
Part 2 of 7
ANTISEPTIC TOWELETTE 
benzalkonium chloride swab
Product Information
Item Code (Source)NDC:50814-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-002-011 in 1 BOX
14.5 g in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/08/2018
Part 3 of 7
BURN TREATMENT 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:50814-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-014-0110 in 1 BOX
10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/08/2018
Part 4 of 7
ALCOHOL CLEANSING 
isopropyl alcohol cloth
Product Information
Item Code (Source)NDC:50814-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-012-0120 in 1 BOX
10.9 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/08/2018
Part 5 of 7
ANTIBIOTIC APPLICATION 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Item Code (Source)NDC:50814-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-013-0110 in 1 BOX
10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B02/08/2018
Part 6 of 7
HAND SANITIZER 
alcohol gel
Product Information
Item Code (Source)NDC:50814-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-015-016 in 1 BOX
10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/08/2018
Part 7 of 7
EYE WASH 
water solution
Product Information
Item Code (Source)NDC:50814-010
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER991 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-010-011 in 1 BOX
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart349B02/08/2018
Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
Establishment
NameAddressID/FEIBusiness Operations
GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-031, 50814-011, 50814-002, 50814-014, 50814-012, 50814-013, 50814-015, 50814-010)

Revised: 10/2018
Document Id: 789960be-2b27-f292-e053-2991aa0a13a2
Set id: 64c7f5c3-cfd8-f5f2-e053-2991aa0a1e9c
Version: 2
Effective Time: 20181019
 
GFA Production (Xiamen) Co., Ltd.