Circata
Capsaicin
Puretek Corporation
Human Otc Drug
NDC 59088-433Circata also known as Capsaicin is a human otc drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Circata is 59088-433. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Circata drug includes Capsicum Oleoresin - .05 g/100g . The currest status of Circata drug is Active.
Drug Information:
| Drug NDC: | 59088-433 |
| 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: | Circata |
| 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: | Puretek Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | CAPSICUM OLEORESIN - .05 g/100g
|
| 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: | 02 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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, 2024 |
| 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: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 200083
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0359088433058
|
| UPC stands for Universal Product Code. |
| UNII: | UW86K581WY
|
| 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 |
|---|
| 59088-433-05 | 57 g in 1 TUBE (59088-433-05) | 02 Sep, 2021 | 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:
Purpose topical analgesic
Product Elements:
Circata capsaicin polyoxyl 100 stearate water aloe vera leaf arnica montana flower glycerin phenoxyethanol capsicum oleoresin capsicum oleoresin capsaicin calcium pantothenate cetostearyl alcohol niacinamide pyridoxine hydrochloride calendula officinalis flower chamomile dimethicone .alpha.-tocopherol acetate, dl- ginkgo laureth-7 lavender oil maltodextrin alkyl (c12-15) benzoate hyaluronate sodium octenylsuccinic acid glyceryl monostearate myristyl myristate levomenol c13-14 isoparaffin carthamus tinctorius (safflower) oleosomes sodium ascorbyl phosphate isopropyl myristate polyacrylamide (10000 mw) silicon dioxide ginger
Indications and Usage:
Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings:
Warnings for external use only this is not a face cream. do not apply to the face. do not use at the same time with other topical analgesics do not use if allergic to chili peppers or if past allergic reaction to capsaicin. do not apply to wounds or damaged, broken, sunburned, chapped, or irritated skin. do not bandage tightly. do not apply within 1 hour before or after bath, shower, hot tub, sauna, or vigorous exercise. warm water, perspiration, or open pores can intensify the impact of this product and burning sensation. do not use with heating pad, hot water bottle or other source of heat. doing so can increase risk of serious burn. when using this product do not get into the eyes and avoid contact with other mucous membranes. if contact occurs or if pain, discomfort, or skin redness occurs, continually rinse with cool water and seek medical help. discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within
Read more...a few days. stop using and get immediate medical attention if experience burning, pain, swelling, or blistering of the skin. rare cases of severe burning or blistering have been reported. if pregnant, breast- feeding or any medical conditions exist, ask a health professional before use. keep out of reach of children and pets. if swallowed, get medical help or contact a poison control center right away. if inhaled, remove to fresh air. if breathing is difficult, get medical attention immediately.
Do Not Use:
Warnings for external use only this is not a face cream. do not apply to the face. do not use at the same time with other topical analgesics do not use if allergic to chili peppers or if past allergic reaction to capsaicin. do not apply to wounds or damaged, broken, sunburned, chapped, or irritated skin. do not bandage tightly. do not apply within 1 hour before or after bath, shower, hot tub, sauna, or vigorous exercise. warm water, perspiration, or open pores can intensify the impact of this product and burning sensation. do not use with heating pad, hot water bottle or other source of heat. doing so can increase risk of serious burn. when using this product do not get into the eyes and avoid contact with other mucous membranes. if contact occurs or if pain, discomfort, or skin redness occurs, continually rinse with cool water and seek medical help. discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. stop using and get immediate medical attention if experience burning, pain, swelling, or blistering of the skin. rare cases of severe burning or blistering have been reported. if pregnant, breast- feeding or any medical conditions exist, ask a health professional before use. keep out of reach of children and pets. if swallowed, get medical help or contact a poison control center right away. if inhaled, remove to fresh air. if breathing is difficult, get medical attention immediately.
When Using:
When using this product do not get into the eyes and avoid contact with other mucous membranes. if contact occurs or if pain, discomfort, or skin redness occurs, continually rinse with cool water and seek medical help.
Dosage and Administration:
Directions before using on children under 18 years of age consult a physician. apply sparingly to affected area not more than 4 times daily. however, for first use, apply to small area to test for sensitivity or skin reaction gently massage into the skin until fully absorbed wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
Stop Use:
Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. stop using and get immediate medical attention if experience burning, pain, swelling, or blistering of the skin. rare cases of severe burning or blistering have been reported. if pregnant, breast- feeding or any medical conditions exist, ask a health professional before use.
Package Label Principal Display Panel:
Circataâ⢠manufactured in the usa by: puretek corporation san fernando, ca 91340 for questions or information call toll-free: 877-921-7873 label
Further Questions:
Questions or comments? for questions or information call toll-free: 877-921-7873