Rite Aid Capsicum Hot
Capsaicin
Rite Aid Corporation
Human Otc Drug
NDC 11822-7448Rite Aid Capsicum Hot also known as Capsaicin is a human otc drug labeled by 'Rite Aid Corporation'. National Drug Code (NDC) number for Rite Aid Capsicum Hot is 11822-7448. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Rite Aid Capsicum Hot drug includes Capsaicin - .6 mg/1 . The currest status of Rite Aid Capsicum Hot drug is Active.
Drug Information:
| Drug NDC: | 11822-7448 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Rite Aid Capsicum Hot |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Capsaicin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rite Aid Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Patch |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CAPSAICIN - .6 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 30 Nov, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | RITE AID CORPORATION
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0011822574488
|
| UPC stands for Universal Product Code. |
| UNII: | S07O44R1ZM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11822-7448-1 | 3 PATCH in 1 POUCH (11822-7448-1) | 19 May, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Uses temporarily relieves minor pain associated with: arthritis simple backache strains sprains bruises
Product Elements:
Rite aid capsicum hot capsaicin zinc oxide lanolin methyl salicylate natural latex rubber peppermint oil petrolatum rosin capsaicin capsaicin
Indications and Usage:
Directions adults and children 12 years of age and older: clean and dry affected area remove patch from film apply to affected area no more than 3 to 4 times daily do not wear patch for more than 8 hours children under 12 years of age: consult a doctor
Warnings:
Warnings for external use only allergy alert: do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
Do Not Use:
Warnings for external use only allergy alert: do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
When Using:
When using this product do not use otherwise than as directed avoid contact with eyes and mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower
Dosage and Administration:
Distributed by: rite aid, 30 hunter lane camp hill, pa 17011 made in china
Stop Use:
Stop use and ask a doctor if conditions worsens, symptoms persist more than 7 days or clear up and occur again within a few days redness is present or irritation or rash develops a severe burning sensation occurs
Package Label Principal Display Panel:
57448