CIRCATRIX- capsaicin cream 
PureTek Corporation

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.

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Circatrix™

0.05% Capsaicin

01-14-2022 - Edit marketing date from 03-01-2022 to 01-14-2022.

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

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

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)

Revised: 1/2022
Document Id: d5923cc2-19c3-1e42-e053-2995a90a6a08
Set id: cd3b1256-2df8-dc26-e053-2a95a90ad049
Version: 3
Effective Time: 20220114
 
PureTek Corporation