FDA Label for Circata
View Indications, Usage & Precautions
Circata Product Label
The following document was submitted to the FDA by the labeler of this product Puretek Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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.
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.
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
Questions Or Comments?
For questions or information call toll-free: 877-921-7873
Circata™
Manufactured in the USA by:
PureTek Corporation
San Fernando, CA 91340
For questions or information
call toll-free:
877-921-7873
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