Otc - Active Ingredient
Menthol 6%
Camphor 3%
Cooling Pain Relief Gel
FDA Label NDC 49283-581
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chemco Corporation for the product Cooling Pain Relief (NDC 49283-581). 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 - active ingredient, otc - purpose, use, warnings, otc - when using, stop use and ask a doctor if, if pregnant or breast-feeding, otc - 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
Otc - 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
Otc - When Using
- Use only as directed
- Do not bandage tightly or use with a heating pad
- Avoid contact with eyes and mucous membranes
- Do not apply to wounds or damaged, broken, or irritated skin
- 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 expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
- Condition worsens.
- Redness is present
- Irritation develops
- Symptoms persist for more than 7 days or clear up occur again within a few days
- You experience signs injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Otc - 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
- Apply a small amount on the affected area.
- Massage in a circular motion until absorbed, let set for a few seconds.
- Repeat as needed, but no more than 3 to 4 times per day.
- Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
- Wash hands with soap and water after use.
Children under 12 years of age consult a doctor.
Inactive Ingredient
Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa (Hemp) Seed Oil, Benzyl Alcohol, Sorbic Acid, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).
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