NDC 50814-042 Fak Care4 Bus And School Yellow Orm D

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Benzalkonium Chloride, Lidocaine Hydrochloride, Isopropyl Alcohol, Benzocaine, Alcohol

NDC Product Code 50814-042

NDC CODE: 50814-042

Proprietary Name: Fak Care4 Bus And School Yellow Orm D What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Benzalkonium Chloride, Lidocaine Hydrochloride, Isopropyl Alcohol, Benzocaine, Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 50814 - Gfa Production (xiamen) Co., Ltd.
    • 50814-042 - Fak Care4 Bus And School Yellow Orm D

NDC 50814-042-01

Package Description: 1 KIT in 1 KIT * 2 BAG in 1 KIT > .9 g in 1 BAG (50814-007-01) * 2 PACKAGE in 1 KIT > .9 g in 1 PACKAGE (50814-009-01) * 2 BOX in 1 KIT > 1 BAG in 1 BOX (50814-039-01) > .45 g in 1 BAG * 2 POUCH in 1 KIT > .53 mL in 1 POUCH (50814-041-02) * 2 BOX in 1 KIT > 1 POUCH in 1 BOX (50814-002-01) > .45 g in 1 POUCH

NDC Product Information

Fak Care4 Bus And School Yellow Orm D with NDC 50814-042 is a a human over the counter drug product labeled by Gfa Production (xiamen) Co., Ltd.. The generic name of Fak Care4 Bus And School Yellow Orm D is bacitracin zinc, neomycin sulfate, polymyxin b sulfate, benzalkonium chloride, lidocaine hydrochloride, isopropyl alcohol, benzocaine, alcohol. The product's dosage form is kit and is administered via form.

Labeler Name: Gfa Production (xiamen) Co., Ltd.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gfa Production (xiamen) Co., Ltd.
Labeler Code: 50814
FDA Application Number: part333B What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-08-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fak Care4 Bus And School Yellow Orm D Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

First aid antisepticPain relieving cream

Antiseptic

Topical Anesthetic





Antiseptic

Use

  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

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.

• 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.

• 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.

• 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.

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

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

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.

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.

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.

  • Clean the affected areaAdults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times dailyChildren under 2 years of age: consult a doctorMay be covered with a sterile bandage

Other Information

Store at room temperature

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

Inactive Ingredients

Mineral Oil, petrolatum, purified water

Glycerin monostearate, glycerol, purified water

Active Ingredients

Benzalkonium chloride 0.13%Lidocaine hydrochloride 0.5

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.

Other Information

Store at room temperature

Active Ingredient:

Isopropyl Alcohol, 70% v/v

Benzalkonium Chloride 0.13%

Benzocaine, 6% w/vSD alcohol,  60% w/v

Use:

For preparation of the skin before injection.

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

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

Warnings:

For external use only.Flammable: keep away from fire or flame.

For external use only.

For external use only.

Do Not Use:

With electrocautery, in the eyes

In the eyes, or over large areas of the body.

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

Stop Use

If irritation and redness develop. if condition persists for more than 72 hours, consult your doctor.

Directions:

Wipe injection site vigorously and discard.

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive Ingredient:

Purified water.

Purified water.

Purpose:

First Aid Antiseptic

Inactive Ingredients:

Purified water.

* Please review the disclaimer below.