Musclecare
FDA Label NDC 24488-026

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Active And Innovative for the product Musclecare (NDC 24488-026). 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 ingredients, purpose, uses:, warnings:, keep out of reach of children, directions:, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor 4.0%

Menthol 10.0%

Purpose

Analgesic (Pain Relief)

Analgesic (Pain Relief)

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings:

For external use only.

  • Caution: Discontinue use if excessive  irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with in a few days, discontinue use of this products and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.

Keep Out Of Reach Of Children

  • Use only as directed.
  • Do not use if pregnant or breastfeeding.
  • If swallowed, get medical help or contact a Poison Control center right away.

Directions:

Adults and children 12 years of age or older. Using the roll-on applicator, message a liberal amount of gel directly on the affected area not more than 3 to 4 daily. Children under the age of 12: Do not use, consult a doctor.

Storage And Handling

Store under normal storage conditions. Store away from children.

Inactive Ingredients

Alcohol Denat, Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Propylene Glycol, Glycerin, MSM (Methylsulfonymethane), Boswellia Serrata Extract,  Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine

Questions?

416-967-3746

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