NDC 72127-0803 Forticept Wounds And Burns Hydrogel

Benzethonium Chloride, Lidocaine Hydrochloride

NDC Product Code 72127-0803

NDC CODE: 72127-0803

Proprietary Name: Forticept Wounds And Burns Hydrogel 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: Benzethonium Chloride, Lidocaine Hydrochloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 72127 - Lidan, Inc.
    • 72127-0803 - Forticept Wounds And Burns Hydrogel

NDC 72127-0803-0

Package Description: .114 kg in 1 TUBE

NDC Product Information

Forticept Wounds And Burns Hydrogel with NDC 72127-0803 is a a human over the counter drug product labeled by Lidan, Inc.. The generic name of Forticept Wounds And Burns Hydrogel is benzethonium chloride, lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Lidan, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Forticept Wounds And Burns Hydrogel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZETHONIUM CHLORIDE .001 kg/kg
  • LIDOCAINE .04 kg/kg

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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LAURETH-7 (UNII: Z95S6G8201)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • POLIHEXANIDE (UNII: 322U039GMF)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-21 (UNII: 53J3F32P58)
  • THYMOL (UNII: 3J50XA376E)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Lidan, Inc.
Labeler Code: 72127
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-06-2020 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.

Forticept Wounds And Burns Hydrogel Product Label Images

Forticept Wounds And Burns Hydrogel 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

Drug Facts

Active Ingredient/Purpose:LIDOCAINE HCL (4.0%)..........................Topical AnalgesicBENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

Uses:

For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

Indications & Usage

Topical analgesic - for temporary relief of pain or discomfort for superficial and full thickness burns or wounds.Topical antiseptic - to help decrease the risk of wounf and skin infections.

Warnings:

For external use only!

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immidiately.

Otc - When Using

When using this product avoid contact with eyes.

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor.

Otc - Stop Use

Discontinue Use after 7 days unless directed by a doctor

Directions:

Adults and children 2 years of age and older:• Clean affected area from dirt and debris, let it dry.• Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed.• Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

Otc - Ask Doctor

For children under 2 years of age: please, consult a doctor

Inactive Ingredients:

ALLANTOIN, ALPHA TOCOPHEROL, C13-14 ISOPARAFFIN, CETOSTEARYL ALCOHOL, CHLORPHENESIN, D-PANTHENOL, FD&C BLUE #1, GLYCERIN, HYDROLYZED COLLAGEN, LANOLIN, LAURETH-7, PARAFFINUM LIQUIDUM, PETROLATUM, POLYACRYLAMIDE, POLYHEXANIDE, SHEA BUTTER, STEARETH-2, STEARETH-21, THYMOL, WATER

Storage And Handling:

  • Keep container closed when not in use. Store at room temperature, avoid freezing.Do not store below 32F/00C or above 95F/350C for extended periods of time.

For Questions:

Lidan, Inc.30 Wall Street, 8th FloorNew York, NY 10005www.forticept.comPlease call: +1 212 709-8133

* Please review the disclaimer below.