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  5. Label Information: Capsaicin Heat Patches Pain Relief

FDA Label for Capsaicin Heat Patches Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ALLERGY ALERT
    6. DO NOT USE:
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAST-FEEDING
    10. KEEP OUT OF REACH OF CHILDREN
    11. INACTIVE INGREDIENTS:
    12. DIRECTIONS:
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS
    16. LABEL

Capsaicin Heat Patches Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid. 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.

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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