Capsaicin Patch
FDA Label NDC 79643-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacure Llc for the product Capsaicin (NDC 79643-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                                     purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Description (Image 012)

Image Description (Image 012)

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