NDC 0536-1264 Rugby Capsaicin Cream

Capsaicin

NDC Product Code 0536-1264

NDC 0536-1264-56

Package Description: 1 TUBE in 1 BOX > 42.5 g in 1 TUBE

NDC Product Information

Rugby Capsaicin Cream with NDC 0536-1264 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Capsaicin Cream is capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rugby Laboratories

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.

Rugby Capsaicin Cream 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.

  • CAPSAICIN .1 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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.
  • 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: Rugby Laboratories
Labeler Code: 0536
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: 02-17-2020 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.

Rugby Capsaicin Cream Product Label Images

Rugby Capsaicin Cream 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 0.1%

Purpose

Topical Analgesic

Warnings

  • For external use only: TEST FIRST ON SMALL AREA OF SKIN. When using this product:Use only as directedDo not apply to wounds, damaged, broken or irritated sinDo not use if you are allergic to capssicum or chili peppersAvoid contact with the eyes or mucous membranesA slight burning sensation may occur upon application, but generally disappears after several days of useIf severe burning occurs, discontinue useDo not expose the treated area to heat or direct sunlightDo not bandageDo not use with heating pad

Stop Use And Ask Doctor

  • Stope Use and Ask Doctor if:Condition worsensSymptoms persist for more than 7 days or clear up and occur again within a few days Redness is presentirritation develops

Keep Out Of The Reach Of Children

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

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:Arthritis Simple BackacheStrainsSprainsBruises

If Pregnant Or Breast Feeding

Ask a doctor before use

Directions

  • Adults and Children over 18 years:Apply to affected areaMassage into the painful area until thoroughly absorbedRepeat as necessary but not more than 3 to 4 times dailyWASH HANDS WITH SOAP AND WATER AFTER APPLYINGChildren 18 years and younger: Ask a doctor

Inactive Ingredients

Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate

Questions

Call 1-800-645-2158Distributed By:RUGBY®LABORATORIES17177 N Laurel Park Drive, Suite 233Livonia, MI 48152www.rugbylaboratories.comMade in China

Other Information

Store at room temperature 15°-30°F (59°-86°F)

* Please review the disclaimer below.