Capsaicin Heat Patches Pain Relief Patch
FDA Label NDC 11822-4210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Capsaicin Heat Patches Pain Relief (NDC 11822-4210). 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 ingredients, purpose, uses, warnings, allergy alert, do not use:, when using this product, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Capsaicin: 0.025%...........................Topical Analgesic

Uses

Temporary relief of minor pain of muscles and joints associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Warnings

For External Use Only

Do Not Use:

  • On wounds or damaged skin
  • with pain rubs, medicated lotions, creams, or ointments
  • with heating pads

When Using This Product

  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
  • do not microwave
  • dispose of used patch in a manner that always keeps products away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingest this patch.

Stop Use And Ask A Doctor If:

  • Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • Conditions worsens
  • Symptoms persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Keep Out Of Reach Of Children

if swallowed, contact a poison control center (1-800-222-1222) immediately.

Inactive Ingredients:

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

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
  • use one patch for up to 8 hours
  • Discard after single use
  • Children under 12 years of age: consult a physician

Inactive Ingredients

hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Questions

866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

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