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Capsiderm Patch

Generic Name: menthol, 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.

Active Ingredients:

Menthol .....................  5.00% ..................... Analgesic/Counterirritant

Capsaicin .................. 0.0375% ................... External Analgesic

Analgesic/Counterirritant

External Analgesic

USES:

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritation.

WARNINGS:

  • For external use only
  • Avoid contact with eyes
  • Do not apply to open wounds or damaged skin
  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • Do not bandage tightly
  • Do not use in large quantities, particularly over raw serfaces or blistererd areas.

Keep out of reach of children. ï»¿If swallowed, consult a physician.

If pregnant or breast feeding, consult physician prior to use.

Directions:

  • Clean and dry afected area.
  • Remove patch from backing and apply to affected area.
  • Use only one patch at a time and a maximum of 3 patches per day.
  • Leave patch on affected area for up to 8-hours.
  • Children under 12 should consult physician prior to use.

Other Ingredients:

Acrylic acid, aluminum hydroxide, carmellose sodium, 2 ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxyno, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

For questions or comments call:

Pronova Corporation

Miami, Florida 33155

(866) 703-3508

Capsiderm Patch 
menthol, capsaicin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67555-172
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 5 mg  in 100 mg
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 mg  in 100 mg
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID  
ALUMINUM HYDROXIDE  
CARBOXYMETHYLCELLULOSE SODIUM  
2-ETHYLHEXYL ACRYLATE  
GLYCERIN  
ISOPROPYL MYRISTATE  
METHYL ACRYLATE  
NONOXYNOL-2  
POLYACRYLIC ACID (8000 MW)  
POLYSORBATE 80  
SORBITAN SESQUIOLEATE  
STARCH, POTATO  
TALC  
TARTARIC ACID  
TITANIUM DIOXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:67555-172-15 15 PATCH in 1 CARTON
1 100 mg in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2015
Labeler - Pronova Corp (111421496)
Revised: 02/2015
 
Pronova Corp



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