Generic Name: menthol and capsaicin
Dosage Form: patch
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Captracin - menthol and capsaicin Patch
Sallus Laboratories, LLC
Captracin Patch Description
Captracin Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Captracin is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.
Captracin is a single-use patch stored in a foil pouch. Each Captracin Patch is 7.6 cm x 12.7 cm (97 cm²) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.
The empirical formula for capsaicin is C H NO , with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:
The empirical formula for menthol is C H O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:
Each Captracin Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Captracin Patch contains the following inactive ingredients: Non-Toxic Acrylic.
Indications and Usage for Captracin Patch
Captracin Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Captracin Patch is an external analgesic/counterirritant.
Captracin Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.
- For external use only.
- Use only as directed.
- Avoid contact with eyes and mucous membranes.
- Do not cover with bandage.
- Do not use on wounds or damaged skin.
- Consult physician for children under 12.
- Do not use if you are allergic to Menthol.
- Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
- KEEP OUT OF REACH OF CHILDREN
Captracin Patch Dosage and Administration
Captracin Patch contains 0.0375% capsaicin and 5.00% menthol.
Instructions for Use
- Clean and dry affected area
- Tear open pouch. Unseal bag and remove patch
- Remove protective film and apply directly to area of pain
- Apply to affected area not more than 3 times daily
- Wash hands with soap after applying patch
- Reseal pouch containing unused patches
|Adults and children 12 years and over||
|Children under 12 years||
How is Captracin Patch Supplied
Captracin Patch is supplied in cartons with 5 re-sealable pouches containing 3 patches each.
NDC 69036-098-15 15 Patches per carton
Storage: Store below 25°C. Avoid direct sunlight.
Manufactured for and Distributed by:
SALLUS LABORATORIES, LLC
Birmingham, AL 35242
Made in USA
Principal Display Panel
NDC # 69036-098-15
Captracin, USP 0.0375%
Menthol, NF 5.00%
menthol and capsaicin patch
|Labeler - Sallus Laboratories, LLC (079418254)|