FDA Label for Capsaicin
View Indications, Usage & Precautions
Capsaicin Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacure Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Capsaicin 0.035%
Purpose
Topical Anesthetic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, bruises, sprains, and strains
Warnings
For external use only. Use only as directed or as directed by a health care professional
Do not use
• On wounds, cuts, damaged or infected skin
• On eyes, mouth, genitals, or any other mucous membranes
Stop use and ask a physician:
• rash, itching or excessive skin irritation develops.
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.
When using this product
• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
• Avoid contact with the eyes, lips, nose and mucous membranes
• Do not tightly wrap or bandage the treated area
• Do not apply heat to the treated area immediately before or after use
Otc - Keep Out Of Reach Of Children
Directions
Adults and children 18 years of age and over:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
Instructions for use :
- Clean and dry the affected area.
- Open pouch and remove one patch.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Discontinue use at least 1 hour before a bath or shower and do not use immedieately after a bath or shower.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 18 years: Ask a physician
Other Information
- Some individuals may not experience pain relief until several minutes or hours after applying the patch
- Store in a cool, dry place
- Protect product from excessive moisture or sunlight
- Store at 67-77° F ( 19-25° C)
Inactive Ingredients
Adhesive, myrrh gum, zinc oxide
Product Label
* Please review the disclaimer below.
