1. Home
  2. Labeler Index
  3. American Sales Company
  4. 41520-911
  5. Label Information: Medicated Pain Relief

FDA Label for Medicated Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USING IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PACKAGE LABEL

Medicated Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. 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 Ingredient



Menthol 5%

Purpose



Topical analgesic

Use



  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • simple backache
      • arthritis
        • bruises
          • sprains

Warnings



For external use only


Do Not Use



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

Ask A Doctor Before Using If You Have



  • redness over the affected area

When Using This Product



  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


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 not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other Information



  • store at 20° to 25°C (68°F to 77°F)



Inactive Ingredients



Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide


Package Label



Pain Relieving Patch

image of carton label - careonepatch.carton

image of carton label - careonepatch.carton


* Please review the disclaimer below.