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  5. Label Information: Capsaicin

FDA Label for Capsaicin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT                                     PURPOSE
    2. USES
    3. WARNINGS
    4. DIRECTIONS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. PRODUCT LABEL

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                                     Purpose



Capsaicin 0.05%                                      Topical Analgesic


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:

  • If rash, itching, or excessive skin irritation develops.
  • If conditions worsen.
  • If symptoms persist for more than 7 days.
  • If symptoms clear up and occur again within a few days.
  • Keep out of reach of children and pets.
  • 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.

    • Do not apply heat to the treated area immediately before or after use


Directions



Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave the patch on for more than 8 hours at a time.

Instructions for use:

  • Clean and dry the affected area.
  • Open the pouch and remove one patch.
  • Remove any protective film and apply directly to the affected area of pain. Apply immediately after removal from the protective envelope.

    • - Wash your hands with soap and water after handling the patches.

    • Reseal pouch containing unused patches after each use. Do not store the patch outside the sealed envelope.
    • 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 and dry place.
  • Store at 67°-77°F (19°-25° C)
  • Protect the product from excessive moisture or sunlight.

Inactive Ingredients



Adhesive, myrrh gum, zinc oxide


Product Label



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