NDC 59088-433 Circata

Capsaicin

NDC Product Code 59088-433

NDC Product Information

Circata with NDC 59088-433 is a a human over the counter drug product labeled by Puretek Corporation. The generic name of Circata is capsaicin. The product's dosage form is cream and is administered via topical form.

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.

Circata 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.

  • POLYOXYL 100 STEARATE (UNII: YD01N1999R)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CHAMOMILE (UNII: FGL3685T2X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • GINKGO (UNII: 19FUJ2C58T)
  • LAURETH-7 (UNII: Z95S6G8201)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • GINGER (UNII: C5529G5JPQ)

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: Puretek Corporation
Labeler Code: 59088
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: 09-02-2021 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.

Circata Product Label Images

Circata 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

Active Ingredient

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Otc - Do Not Use

  • 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.

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 reactionGently massage into the skin until fully absorbedWash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Storage

WARNING: FLAMMABLE PRODUCTStore in a cool well-ventilated area away from heat. Keep away from sparks or open flame.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Do not use if package is damaged.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Aqua (Purified Water), Arnica Montana Flower Extract, Bisabolol, C12- 15 Alkyl Benzoate, C13- 14 Isoparaffin, Calcium D-Pantothenate, Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL- α- Tocopheryl Acetate, Ginkgo Biloba Leaf Extract, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Laureth- 7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl Myristate, Niacinamide, PEG- 100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine Hydrochloride, Silicon Dioxide, Sodium Ascorbyl Phosphate, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale ( Ginger) Root Extract

Circata​™

Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340

For questions or information

call toll-free:
877-921-7873

* Please review the disclaimer below.