Medicated Pain Relief
FDA Label NDC 41520-911

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Medicated Pain Relief (NDC 41520-911). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, ask a doctor before using if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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