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  5. Label Information: Pain Relieving Patch Ultra Strength Ultra Strength

FDA Label for Pain Relieving Patch Ultra Strength Ultra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relieving Patch Ultra Strength Ultra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. 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.

Otc - Active Ingredient



Active Ingredient
Menthol 5%


Otc - Purpose



Purpose

Topical Analgesic


Indications & Usage



Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor



Ask a doctor before use if you

  • have redness over the affected area
  • are pregnant or breastfeeding

Otc - When Using



When using this product

  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
  • do not use with a heating pad or other heating device

Otc - Stop Use



Stop using this product if

  • condition worsens
  • excessive skin irritation occurs
  • redness is present
  • symptoms persist more than 7 days or clear up and occur again within a few days
    • If pregnant or breastfeeding consult a healthcare professional before use

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily
  • children under 12 years of age consult a doctor
  • For best results, please ensure that the skin is clean and dry before applying
  • reseal pouch

Inactive Ingredient



Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.


Otc - Questions



Questions? Call toll-free 1-800-645-3867


Package Label.Principal Display Panel





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