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NDC 59088-0479-05 Circatrix 0.05 g/100g Details
Circatrix 0.05 g/100g
Circatrix is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is CAPSICUM OLEORESIN.
MedlinePlus Drug Summary
Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.
Related Packages: 59088-0479-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical
Product Information
| NDC | 59088-0479 |
|---|---|
| Product ID | 59088-479_d5923cc2-19c3-1e42-e053-2995a90a6a08 |
| Associated GPIs | 90850025003720 |
| GCN Sequence Number | 082669 |
| GCN Sequence Number Description | capsicum oleoresin CREAM (G) 0.05 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 50971 |
| HICL Sequence Number | 007968 |
| HICL Sequence Number Description | CAPSICUM OLEORESIN |
| Brand/Generic | Brand |
| Proprietary Name | Circatrix |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capsaicin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 0.05 |
| Active Ingredient Units | g/100g |
| Substance Name | CAPSICUM OLEORESIN |
| Labeler Name | PureTek Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59088-0479-05 (59088047905)
| NDC Package Code | 59088-479-05 |
|---|---|
| Billing NDC | 59088047905 |
| Package | 57 g in 1 TUBE (59088-479-05) |
| Marketing Start Date | 2022-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cd3b1256-2df8-dc26-e053-2a95a90ad049 Details
Uses
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.
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
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
Circatrix™
INGREDIENTS AND APPEARANCE
| CIRCATRIX
capsaicin cream |
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| Labeler - PureTek Corporation (785961046) |