Otc - Purpose
For muscle and joint pain relief
Professional Therapy Musclecare Pain Relieving Ointment
FDA Label NDC 70039-300
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 Pain Relieving (NDC 70039-300). 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, use:, 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
Menthol 4.0%...........................Analgesic (pain relief)
Camphor 4.0%........................Analgesic (pain relief)
Use:
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.
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 you are 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: Rub this soothing cream onto the effected 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:Dimethyl sulfone (MSM), Gluosamine sulfate, Tocopherol (natural Vitamin E), Safflower Oleosomes (Carthamus Tinctorius), Wintergreen leaf oil (Gaultheria fragrantissima Wall), Eucalyptus leaf oil 9Eucalyptus globus), Grape seed oil (Vitis vinifera), Aloe babadensis leaf juice, Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Chondroitin sulfate, Cetyl alcohol, Cetearyl alcohol & Polysorbate-20, Glycerin, Acacia Senegal Gum & Xanthan Gum, Urea, Phenoxyethanol & ethylhexyl glycerin, Water, Magnesium chloride.
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