Capsaicin Heat Patches Back And Large Areas Patch
FDA Label NDC 41250-842

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Capsaicin Heat Patches Back And Large Areas (NDC 41250-842). 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 for external use only, uses, purpose, active ingredients, inactive ingredients:, directions for use:, keep out of reach of children, storage and care:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

For External Use Only

  • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
  • Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.

Uses

Temporary relief of minor pain associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Purpose

Temporary relief of minor pain associated with: arthritis, minor backache, muscle strains,
muschle sprains, bruises

Active Ingredients

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

Inactive Ingredients:

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

Directions For Use:

For Use on Adults and Childrens 12 Years of Age or Older

  • Clean and dru affected area; ensure area is fully dry before application
  • Remove patch from film
  • Apply to treatement site
  • Patch may be trimmerd to best fit treatment site; trim patch before removing film
  • Wash hands after application
  • Discard after signle use
    • Caution:
    • Take care when using on elderly ot incapacited persons
    • Do not use more than 8 hours
    • Do not use the Capsaicin Heat Patch more than 3-4 times daily
    • Do not exceed 7 days of continue use

Keep Out Of Reach Of Children

if swallowed, contact a poison control center immediately.

Storage And Care:

  • One time use only; do not attempt to reuse the product
  • avoid storage in direct sunlight
  • Protect patch from excessive moisture

Do Not Use:

  • On areas with sensitive skin, open wounds or previous burns
  • with pain rubs, medicated lotions, creams or oinments
  • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site

Use Only As Directed:

  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.

Stop Use Immediately And Seek Medical Attention If:

  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

Questions

866-326-1313

Label

DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

Made in China

Capsaicin Heat Path (Patchimage)

Capsaicin Heat Path (Patchimage)

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