NDC 61787-442 Zostrix Original Strength

Capsaicin

NDC Product Code 61787-442

NDC 61787-442-02

Package Description: 1 TUBE in 1 CARTON > 56.6 g in 1 TUBE

NDC Product Information

Zostrix Original Strength with NDC 61787-442 is a a human over the counter drug product labeled by Akorn Consumer Health. The generic name of Zostrix Original Strength is capsaicin. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1803727 and 213109.

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.

Zostrix Original Strength 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Akorn Consumer Health
Labeler Code: 61787
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: 01-09-2006 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.

Zostrix Original Strength Product Label Images

Zostrix Original Strength 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

Capsaicin 0.025%

Purpose

Topical Analgesic

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a PoisonControlCenter immediately.

Uses

  • •for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Warnings

For external use only.Do not apply to wounds or to damaged or irritated skin.

When Using This Product

  • •you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days. •avoid contact with eyes. Do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water. •do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise •do not apply heat to the treated areas immediately before or after use •do not tightly wrap or bandage the treated area •avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

Stop Use And Ask A Doctor If

  • •condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor •blistering occurs •difficulty breathing or swallowing occurs •severe burning persists

Directions

  • •for persons under 18 years of age, ask a doctor before using •apply a thin film of cream and gently rub in until fully absorbed •for optimum relief, apply 3 to 4 times daily •best results typically occur after 2 to 4 weeks of continuous use •unless treating hands, wash hands thoroughly with soap and water immediately after use •see package insert for more information

Other Information

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

Benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

* Please review the disclaimer below.