Label: FAK CARE4 BUS AND SCHOOL YELLOW ORM D- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol kit

  • NDC Code(s): 50814-001-01, 50814-002-01, 50814-007-01, 50814-009-01, view more
    50814-030-01, 52124-0008-1
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

If you are a consumer or patient please visit this version.

  • First Aid Antibiotic Ointment, 0.9g (50814-007-01) Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc (bacitracin 400 units)

    Neomycin sulfate (neomycin 3.5 mg)

    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

    • Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients

    • 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 • 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

  • First Aid Antiseptic Pain Relieving Cream, 0.9g (50814-009-01) 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 reach 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 Pad (50814-001-01) 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.

  • 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.

  • Insect Sting Relief Pad (52124-0008-1) DRUG FACTS

  • Active Ingredient:

    Benzocaine, 6% w/v

    SD alcohol,  60% w/v

    Purpose

    Topical Anesthetic Antiseptic

  • Use:

    For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

  • Warnings:

    For external use only.

    Do not use:

    In eyes, on broken skin, deep puncture wounds. If unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately.

    Keep out of reach of children.

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

    Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

  • Inactive Ingredients:

    Purified water.

  • Package Labeling:

    KitKit2

  • First Aid Antibiotic Ointment, 0.9g

    First Aid Antibiotic

  • First Aid Antiseptic Pain Relieving Cream, 0.9g

    First Aid Antiseptic Pain

  • Alcohol Cleansing Pad

    Alcohol Cleansing Pad

  • Antiseptic Towelette

    Antiseptic Towelette

  • Insect Sting Relief Pad

    Insect Sting Relief Pad

  • INGREDIENTS AND APPEARANCE
    FAK CARE4 BUS AND SCHOOL YELLOW ORM D 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-030
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-030-011 in 1 KIT02/08/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BAG 1.8 g
    Part 22 PACKAGE 1.8 g
    Part 32 BAG 0.9 g
    Part 42 POUCH 0.9 g
    Part 52 PACKAGE 1 mL
    Part 1 of 5
    FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:50814-007
    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
    12 in 1 KIT
    1NDC:50814-007-010.9 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/08/2018
    Part 2 of 5
    FIRST AID ANTISEPTIC PAIN RELIEVING 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Item Code (Source)NDC:50814-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    1NDC:50814-009-010.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/08/2018
    Part 3 of 5
    ALCOHOL CLEANSING 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:50814-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    1NDC:50814-001-011 in 1 BOX
    10.45 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 DrugM00302/08/2018
    Part 4 of 5
    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
    12 in 1 KIT
    1NDC:50814-002-011 in 1 BOX
    10.45 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/08/2018
    Part 5 of 5
    INSECT STING RELIEF PAD 
    benzocaine,alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.6 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    1NDC:52124-0008-10.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00402/08/2018
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-030, 50814-007, 50814-009, 50814-001, 50814-002, 52124-0008)