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| Product NDC Code | 59088-479 | ||||
|---|---|---|---|---|---|
| Drug Name | Circatrix |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 200083 | ||||
| Application Number | part348 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Capsicum Oleoresin (Containing Capsaicin 0.05%)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Circatrix Capsaicin POLYOXYL 100 STEARATE WATER ALOE VERA LEAF ARNICA MONTANA FLOWER GLYCERIN PHENOXYETHANOL CAPSICUM OLEORESIN CAPSICUM OLEORESIN CAPSAICIN LAURETH-7 CALCIUM PANTOTHENATE CETOSTEARYL ALCOHOL NIACINAMIDE PYRIDOXINE HYDROCHLORIDE CALENDULA OFFICINALIS FLOWER CHAMOMILE DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE, DL- GINKGO LAVENDER OIL MALTODEXTRIN ALKYL (C12-15) BENZOATE MYRISTYL MYRISTATE HYALURONATE SODIUM OCTENYLSUCCINIC ACID GLYCERYL MONOSTEARATE GINGER LEVOMENOL C13-14 ISOPARAFFIN CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES SODIUM ASCORBYL PHOSPHATE ISOPROPYL MYRISTATE POLYACRYLAMIDE (10000 MW) SILICON DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Circatrix™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? For questions or information call toll-free: 877-921-7873
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Storage and handling
Information about safe storage and handling of the drug product.Storage WARNING: FLAMMABLE PRODUCT Store 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API