Capsaicin Patch
FDA Label NDC 79643-007

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 79643-007). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Description (Image 007 1)

Image Description (Image 007 1)

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