Label: CIRCATRIX- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 14, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    • 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

  • Circatrix​™

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    label

  • INGREDIENTS AND APPEARANCE
    CIRCATRIX 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-479
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY) CAPSAICIN0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GINGER (UNII: C5529G5JPQ)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-479-0557 g in 1 TUBE; Type 0: Not a Combination Product01/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/14/2022
    Labeler - PureTek Corporation (785961046)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!