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  5. Label Information: Healthwise Capsaicin Heat Patch

FDA Label for Healthwise Capsaicin Heat Patch

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. OTHER INFORMATION
    9. DO NOT USE:
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR:
    12. QUESTIONS
    13. IF PREGNANT OR BREAST-FEEDING
    14. LABEL

Healthwise Capsaicin Heat Patch Product Label

The following document was submitted to the FDA by the labeler of this product Veridian Healthcare. 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



  • 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 of muscles and joints 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:



Adults and Childrens 12 Years of Age or Over

  • Clean and dry affected area; free of lotions, ointments 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 after signle use

    • Children under 12 years of age:

    • Consult a physician

Keep Out Of Reach Of Children



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


Other Information



  • avoid storage in direct sunlight
  • Protect patch from excessive moisture

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 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:



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.



Questions



call 1-866-326-1313


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