NDC 11822-7884 Capsaicin

Arthritis Pain Relief

NDC Product Code 11822-7884

NDC 11822-7884-1

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

NDC Product Information

Capsaicin with NDC 11822-7884 is a a human over the counter drug product labeled by Rite Aid. The generic name of Capsaicin is arthritis pain relief. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rite Aid

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.

Capsaicin 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 .001 g/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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Rite Aid
Labeler Code: 11822
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: 02-21-2020 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.

Capsaicin Product Label Images

Capsaicin 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

Otc - Active Ingredient

Active ingredient PurposeCapsaicin 0.1%....................................................Topical analgesic

Otc - Purpose

  • Usestemporarily relieves minor pain of muscles and joints associated with:arthritissimple backachestrainssprainsbruises

Warnings

WarningsFor external use only

Otc - Do Not Use

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

Otc - When Using

  • When using this productavoid contact with the eyes or mucous membranesdo not bandage tightlya transient burning sensation may occur upon application but generally disappears in several daysdo not expose the treated area to heat or direct sunlight

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens, symptoms persist for more than 7 days or clear up and occur again within a few daysredness is present or irriration developsa severe burning sensation occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

  • Directionsadults and children 18 years of age and older:use only as directedapply to affected areamassage into painful area until thoroughly absorbedrepeat as necessary, but no more than 3 to 4 times dailywash hands with soap and water after applyingchildren under 18 years of age: ask a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactivate ingredientsbenzyl alcohol, cetyl alcohol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, purified water, sorbitan monostearate, sorbital

Dosage & Administration

Distributed by:Rite Aid30 Hunter LaneCamp Hill, PA 17011Made in China

* Please review the disclaimer below.