NDC 11822-7309 Rite Aid Pain Relieving Xl Patch With Arnica

Harpagophytum Procumbens

NDC Product Code 11822-7309

NDC 11822-7309-6

Package Description: 1 PACKET in 1 BOX > 6 PATCH in 1 PACKET

NDC Product Information

Rite Aid Pain Relieving Xl Patch With Arnica with NDC 11822-7309 is a a human over the counter drug product labeled by Rite Aid. The generic name of Rite Aid Pain Relieving Xl Patch With Arnica is harpagophytum procumbens. The product's dosage form is patch and is administered via topical form.

Labeler Name: Rite Aid

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Rite Aid Pain Relieving Xl Patch With Arnica 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.

  • SALIX ALBA BARK .5 mg/1
  • BOSWELLIA SERRATA RESIN OIL 1 mg/1
  • HARPAGOPHYTUM PROCUMBENS ROOT 19 mg/1
  • ARNICA MONTANA 3 mg/1

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)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)

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
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 10-21-2020 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.

Rite Aid Pain Relieving Xl Patch With Arnica Product Label Images

Rite Aid Pain Relieving Xl Patch With Arnica 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

Devil's Claw Cut Root [Harpagophytum procumbens] 19mgArnica Montana 3mgBoswellia Serrata Extract 1mgSalix Alba 0.5mg

Inactive Ingredient

Acrylates Copolymer (390mg), Glycerin (130mg), Camphor (2mg), Polysorbate 60 (0.5mg)

Dosage & Administration

  • Open the packaging and remove the patch.Remove the transparent protective film.Apply the patch to the affected area, ensuring it adheres well. Leave on for 24 hours, then replace it with a new one. If necessary, cut the patch to a smaller size using scissors.

Indications & Usage

Temporarily relieves muscle pain and stiffness due to minor injuries, overexcertion and falls

Warnings

For external use only.Avoid contact with eyes, mucous membranes, damaged skin, or wounds.Do not useif you are allergic to any of this product's active or inactive ingredients.
If pregnant or breast-feeding, ask a health professional before use.
Stop use and ask a doctorif symptoms worsen or persist for more than 3 days.
Discontinue treatment in case of skin irritation, redness or rash occurs.
If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Damaged packaging could compromise the operation and safety of the product.Do not use if the packaging is broken or punctured.Disposable Single UseStore in cool, dry place.

Otc - Purpose

Temporary relief of trauma, muscle pain and stiffness

* Please review the disclaimer below.