Best Choice Targeted Warming Capsaicin Heat Patch
FDA Label NDC 63941-691

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers Company for the product Best Choice Targeted Warming Capsaicin Heat Patch (NDC 63941-691). 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, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Uses

Temporary relief of minor pain of muscles and joints associated with: arthritis, minor backache, strains, sprains and bruises

Warnings

For external use only

Do Not Use

  • on wounds or damaged skin
  • with pain rubs, medicated lotions, creams or ointments
  • with a heating pad.

When Using This Product

  • use only as directed
  • avoid contact with the 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 manner that always keeps product 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 ingests this patch.

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, contact a poison control center (1-800-222-1222) right away.

Allergy Alert:

If you are allergic or suspect you are allergic to the ingredients of this product, including chilli peppers, consult with your physician before use.

Directions

Adults and children 12 years of age and over:  Clean and dry affected area, free of lotions, oitments and creams.  Carefully remove backing starting at a corner.  Apply sticky side of patch to affected area.  Do not use more than one patch in an 8 hour period.  Repeat as necessary.  Maximum 3 patches per day.  Discard patch after single use.

Children under 12 years of age: consult a physician.

Other Information

  • Avoid storage in direct sunlight
  • Protect patch from excessive moisture.

Inactive Ingredients

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

Scan Here For More Product Information.

Call 1-844-292-1112 for more product information.

Principal Display Panel

* Please review the disclaimer below.