Skip to Content

Captracin Patch

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.

Contraindications

Captracin Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

  • 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

Directions

 Adults and children 12 years and over      
  • apply to affected area
  • change patch 1 to 2 times daily
 Children under 12 years
  • consult physician before use

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
205-314-4780

Made in USA

Principal Display Panel
NDC # 69036-098-15
RX Only
Captracin
Captracin, USP 0.0375%
Menthol, NF 5.00%
15 Patches

CAPTRACIN 
menthol and capsaicin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69036-098
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 5 g
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID  
Packaging
# Item Code Package Description
1 NDC:69036-098-15 5 POUCH in 1 CARTON
1 3 PATCH in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2014
Labeler - Sallus Laboratories, LLC (079418254)
Revised: 12/2014
 
Sallus Laboratories, LLC



More about capsaicin/menthol topical

Consumer resources

Professional resources

Related treatment guides

Hide