Capsaicin Pain Relief Patch
FDA Label NDC 67510-0303

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Capsaicin Pain Relief (NDC 67510-0303). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic products
  • if you are allergic to any ingredients of this product

When Using This Product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes

Stop Use And Ask A Doctor If

  • 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 right away.

Directions

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area not more than 3 to 4 times daily for 7 days
  • Remove patch from the skin after at most 8 hour's application
    • Children under 12 years of age:
    • Consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

Butylated Hydroxytoluene, Hydrogenated Rosin Glycerol Ester, Maleated Rosin Glycerin Ester, Natural Rubber, Polybutene, Polyisobutylene, Silicon Dioxide, Titanium Dioxide, Zinc Oxide

Package Label

Capsaicin Hot Patch

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