NDC 70000-0517 Docosanol

Docosanol

NDC Product Code 70000-0517

NDC 70000-0517-1

Package Description: 1 TUBE in 1 PACKAGE > 2 g in 1 TUBE

NDC Product Information

Docosanol with NDC 70000-0517 is a a human over the counter drug product labeled by Cardinal Health (leader) 70000. The generic name of Docosanol is docosanol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cardinal Health (leader) 70000

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Docosanol 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.

  • DOCOSANOL 100 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE DISTEARATE (UNII: 33X4X4B90S)
  • SUCROSE STEARATE (UNII: 274KW0O50M)

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: Cardinal Health (leader) 70000
Labeler Code: 70000
FDA Application Number: ANDA208754 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 09-17-2019 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.

Docosanol 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

Docosanol  10%

Purpose

Cold sore/fever blister treatment

Uses

  • Treats cold sores/fever blisters on the face or lipsshortens healing time and duration of symptoms:tingling, pain, burning, and/or itching

Warnings

  • Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include:hivesfacial swellingwheezing/difficultyshockrashIf an allergic reaction occurs, stop use and seek medical help right away.For external use only

Do Not Use

  • If you are allergic to any ingredient in this product

When Using This Product

  • Apply only to the affected areasdo not use in or near the eyesavoid applying directly inside your mouthdo not share this product with anyone. This may spread the infection.

Stop Use And Ask A Doctor If

  • Your cold sore gets worse or the cold sore is not healed within 10 days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 12 years or over:wash hands before and after applying creamapply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle).early treatment ensures the best resultsrub in gently but completelyuse 5 times a day until healedchildren under 12 years: ask a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F)do not freeze

Inactive Ingredients

Benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Package Label

LEADER Docosanol Cream, 10%

* Please review the disclaimer below.