Circata™

Circata™
SPL v3
SPL
SPL Set ID b67161d7-cc5c-e971-e053-2995a90acbe7
Route
TOPICAL
Published
Effective Date 2021-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Polyoxyl 100 Stearate Water Aloe Vera Leaf Arnica Montana Flower Glycerin Phenoxyethanol 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-02

Description

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Uses

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

Section 50570-1
  • 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.
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

For external use only

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.
Circata​™

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

For questions or information

call toll-free: 877-921-7873

Active Ingredient

Capsicum Oleoresin (Containing Capsaicin 0.05%)

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

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.


Structured Label Content

Uses

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

Section 50570-1 (50570-1)
  • 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.
Purpose

Topical Analgesic

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

For external use only

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.
Circata​™

Manufactured in the USA by:

PureTek Corporation

San Fernando, CA 91340

For questions or information

call toll-free: 877-921-7873

Active Ingredient (Active ingredient)

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Inactive Ingredients (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? (Questions or comments?)

For questions or information call toll-free: 877-921-7873

When Using This 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.
Discontinue Use and Consult A Doctor If (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. (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.


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