Otc - Purpose
For Muscle and Joint Pain Relief
Professional Therapy Musclecare
FDA Label NDC 70039-200
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 Inc. for the product Professional Therapy Musclecare (NDC 70039-200). 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 otc - purpose, active ingredients (% by weight) purpose, uses:, warnings:, keep out of reach of children:, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (% By Weight) Purpose
Camphor 4.0%.................. Analgesic (pain relief)
Menthol 10.0%...................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 within a few days, discontinue use of this product 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.
Dosage & Administration
Directions: Adults and children 12 years of age or older: Using the roll-on applicator massage a liberal amount of gel directly onto the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.
Storage And Handling
Other Information: Store under normal storage conditions. Store away from children.
Inactive Ingredient
Inactive Ingredients: Peppermint leaf oil (Mentha piperita), Eucalyptus globus leaf oil, Dimethyl sulfone (MSM), Boswellia Carterii Extract, Ilex Paraguariensis (Mate) leaf extract, Glucosamine sulfate, Chondroitin sulfte, Magnesium chloride, Tocopherol (natural Vitamin E), Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Water, Ethanol, Glycerin, UREA, Hydroxypropyl methylcellulose.
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