NDC 69006-002 Viabecline

Tetracycline Hydrochloride

NDC Product Code 69006-002

NDC 69006-002-00

Package Description: 1 BOTTLE in 1 BOX > 5 mL in 1 BOTTLE

NDC Product Information

Viabecline with NDC 69006-002 is a a human over the counter drug product labeled by Viaderma Ii, Inc.. The generic name of Viabecline is tetracycline hydrochloride. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1542813 and 1926470.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Viabecline 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.


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.

  • ACETIC ACID (UNII: Q40Q9N063P)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HISTIDINE (UNII: 4QD397987E)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBIC ACID (UNII: X045WJ989B)
  • 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.

Product Labeler Information

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

Labeler Name: Viaderma Ii, Inc.
Labeler Code: 69006
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: 11-08-2016 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Viabecline Product Label Images

Viabecline 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 Ingredient (In Each Gram)

Tetracycline Hydrochloride 30mg

Purpose

First Aid antibiotic

Use

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

Warnings

  • For esternam use only. May be harmful is swallowed.
  • Allergy alert: Do not use if allergic to any ingredient listed on this label.Do not useIn eyesover large areas of the bodylonger than 1 week unless directed by doctorAsk a doctor before use if you have​deep or puncture woundsanimal bitesserious traumaStop use and ask a doctor if condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep our of reach of children. If swallowed, get medical help or contact a Poison control Center right away.

Directions

  • Clean the affected areaApply 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

  • Keep product refrigerated to preserve its effectiveness and colorStop use if product is misusedThis product is an OTC antibiotic for human useContains no alcohol, no animal ingredientsBlended for typical skin colorMay stain cloth No claims regarding stem cell healing are implied for this product.

Inactive Ingredient

Acetic Acid, Ascorbic Acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, GLYCERIN, histidine, hydroxethylc-cellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, steric acid, water.

* Please review the disclaimer below.