Active Ingredient
Capsicum Oleoresin (Containing Capsaicin 0.05%)
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Circatrix (NDC 59088-479). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, when using this product, discontinue use and consult a doctor if, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Capsicum Oleoresin (Containing Capsaicin 0.05%)
Topical Analgesic
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
For external use only
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.
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.
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.
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
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