NDC 59208-002 Cicloferon

Benzalkonium Chloride And Lidocaine Hydrochloride

NDC Product Code 59208-002

NDC Code: 59208-002

Proprietary Name: Cicloferon 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: Benzalkonium Chloride And 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.

NDC Code Structure

  • 59208 - Laboratorios Liomont, S.a. De C.v.
    • 59208-002 - Cicloferon

NDC 59208-002-04

Package Description: 1 TUBE in 1 CARTON > 4 g in 1 TUBE

NDC 59208-002-05

Package Description: 1 TUBE in 1 CONTAINER > 4 g in 1 TUBE

NDC Product Information

Cicloferon with NDC 59208-002 is a a human over the counter drug product labeled by Laboratorios Liomont, S.a. De C.v.. The generic name of Cicloferon is benzalkonium chloride and lidocaine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Laboratorios Liomont, S.a. De C.v.

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.

Cicloferon 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.

  • BENZALKONIUM CHLORIDE 1.3 mg/g
  • LIDOCAINE HYDROCHLORIDE 20 mg/g

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.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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.

Product Labeler Information

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

Labeler Name: Laboratorios Liomont, S.a. De C.v.
Labeler Code: 59208
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: 05-01-2019 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: 12-31-2020 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.

Cicloferon Product Label Images

Cicloferon 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

Benzalkonium Chloride 0.13%Lidocaine Hydrchloride 2%

Purpose

Topical antisepticTopical analgesic

Uses

  • Provides temporary relief of pain associated with cold sores and fever blisters
  • First aid to help protect against infection in minor cuts, scrapes, burns

Warnings

For external use only:Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.

Do Not Use

  • For more than 7 days unless told to do so by a doctormore than directedif you are allergic to any ingredient in this product

When Using This Product

  • Avoid contact with the eyes

Keep Out Of Reach Of Children

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

Directions

  • Clean the affected areaapply a small amount of this product to the affected area 1 to 3 times dailymay be covered with a sterile bandagechildren under 12 years of age, consult a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Hypromellose, methylparaben, propylene glycol, water, polysorbate 80

* Please review the disclaimer below.

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