NDC 81533-100 Nobleaid Capsaid

Capsaicin

NDC Product Code 81533-100

NDC 81533-100-15

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

NDC Product Information

Nobleaid Capsaid with NDC 81533-100 is a a human over the counter drug product labeled by Noble Otc Llc. The generic name of Nobleaid Capsaid is capsaicin. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 646333.

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.

Nobleaid Capsaid 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.

  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)

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: Noble Otc Llc
Labeler Code: 81533
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: 08-31-2021 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: 12-31-2022 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.

Nobleaid Capsaid Product Label Images

Nobleaid Capsaid 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

Manufactured forNoble OTC LLC788 Convery BlvdPerth Amboy, NJ 08861www.nobleotc.com609-375-2548MADE IN MEXICO

Otc - Active Ingredient

Active ingredientCapsaicin 0.1%.

Otc - Purpose

PurposeTopical Analgesic Cream.

Indications & Usage

  • Uses temporarily relieves minor aches and pains of muscles adn joints due to
  • Arthritissimple backachestrainsbruisessprains

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating padif you are allergic to capsicum or chili peppers

Otc - When Using

  • When using this productavoid contact with the eyes and mucus membranesa transient burning sensation may occur upon application but generally disappears in a few daysdo not bandage tightlydo not apply heat to treated area

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or if symptoms last more than 7 day or clear up and occur again within a few days.redness or irritation develop.a severe burning sensation occurs.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsread all warnings adn directions before use. Test first on a small area of skin.adults and children 18 years of age and older: apply adn massage on to affected area not more than 3 to 4 times daily
  • Children under 18 years of age: ask a doctor

Inactive Ingredient

Inactive ingredienta:Benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-40 hydrogenated castor oil, petrolatum, sorbitol, water

* Please review the disclaimer below.