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  5. Label Information: Capsaicin Hot Patches

FDA Label for Capsaicin Hot Patches

View Indications, Usage & Precautions

Table of Contents

    1. FOR EXTERNAL USE ONLY
    2. USES
    3. PURPOSE
    4. ACTIVE INGREDIENTS
    5. INACTIVE INGREDIENTS:
    6. DIRECTIONS FOR USE:
    7. KEEP OUT OF REACH OF CHILDREN
    8. STORAGE AND CARE:
    9. DO NOT USE:
    10. USE ONLY AS DIRECTED:
    11. STOP USE IMMEDIATELY AND SEEK MEDICAL ATTENTION IF:
    12. QUESTIONS
    13. LABEL

Capsaicin Hot Patches Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



TOLL-FREE

Customer Care Help Line
866-326-1313

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017


Made in China


Label



Capsaicin Hot Path - labelimage

Capsaicin Hot Path - labelimage


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