FAK LARGE OFFICE FIRST AID KIT (BENZALKONIUM CHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]

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  • FAK LARGE OFFICE FIRST AID KIT (BENZALKONIUM CHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]

FAK LARGE OFFICE FIRST AID KIT (BENZALKONIUM CHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]
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NDC 50814-002-01, 50814-010-01, 50814-011-01, 50814-012-01, 50814-013-01, 50814-014-01, 50814-015-01, 50814-031-01
Set ID 64c7f5c3-cfd8-f5f2-e053-2991aa0a1e9c
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 PART349B
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  • 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

    • 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

  • 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

    • 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

    • 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

    • 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

  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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