Active Ingredients
Camphor 3%
Menthol 5%
Core Relief Cream
FDA Label NDC 87179-053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Copper Joint, Llc for the product Core Relief (NDC 87179-053). 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, use, warnings, stop use and ask a doctor if, when using this product, if pregnant or breast – feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
Ask a doctor before use if you have redness over affected area.
Stop Use And Ask A Doctor If
- Redness is present.
- Condition worsens.
- Irritation develops.
- Symptoms persist for more than 7 days or clear up and occur again within a few days.
- You experience signs injury, such as pain, swelling or blistering where the product was applied.
When Using This Product
- Use only as directed.
- Avoid contact with eyes and mucous membranes.
- Do not bandage tightly or use with a heating pad.
- A transient burning sensation or redness may occur upon application but generally disappears in several days.
- If you experience an allergic reaction, discontinue use, and consult a physician.
- Do not apply on large areas of the body or on damaged, broken, or irritated skin.
- Do not expose the area treated with product to heat or direct sunlight.
If Pregnant Or Breast – Feeding
Ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help, or contact a Poison Control Center right away.
Directions
Adults and children over 12 years of age
- Apply a small amount to the affected area.
- Massage in a circular motion, let set for a few seconds.
- Repeat as necessary, but no more than 3 to 4 times daily.
- Wash hands with soap and water after use.
Children under 12 years of age:do not use unless directed by doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°F - 86°F (15°C - 30°C)
Inactive Ingredients
Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycerin, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Methylsulfonylmethane, Panthenol, Phenoxyethanol, Ethylhexylglycerin.
Questions Or Comments?
(615)908-3117
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