NDC 11527-080 Sheffield Arthritis And Muscle Pain Relief

Capsicum Oleoresin

NDC Product Code 11527-080

NDC CODE: 11527-080

Proprietary Name: Sheffield Arthritis And Muscle Pain Relief 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: Capsicum Oleoresin 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

  • 11527 - Sheffield Pharmaceuticals Llc
    • 11527-080 - Sheffield Arthritis And Muscle Pain Relief

NDC 11527-080-60

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

NDC Product Information

Sheffield Arthritis And Muscle Pain Relief with NDC 11527-080 is a a human over the counter drug product labeled by Sheffield Pharmaceuticals Llc. The generic name of Sheffield Arthritis And Muscle Pain Relief is capsicum oleoresin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sheffield Pharmaceuticals Llc

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.

Sheffield Arthritis And Muscle Pain Relief 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.

  • CAPSICUM OLEORESIN .075 g/100g

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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PARAFFIN (UNII: I9O0E3H2ZE)

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: Sheffield Pharmaceuticals Llc
Labeler Code: 11527
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: 12-22-2020 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.

Sheffield Arthritis And Muscle Pain Relief 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

Other

Drug Facts

Active Ingredient

Capsicum Oleoresin 0.075%

Purpose


Uses

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

Warnings

  • For external use only Avoid contact with the eyes and mucous membranesIf 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.Do not apply to wounds or damaged skin.Do not bandage tightly.Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.Discontinue use if excessive irritation of skin develops.If pregnant or breast feeding, ask a health professional before use.A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep This And All Drugs Out Of The Reach Of Children.

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

Directions

  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.Unless treating hands, wash thoroughly with soap and water immediately after use.

Inactive Ingredients

Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

Other Information

  • Store at controlled room temperature 20°- 25°C (68° - 77°F)Close the cap tightly after use

* Please review the disclaimer below.