FDA Label for Sunset Cooling Pain Relief
View Indications, Usage & Precautions
Sunset Cooling Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Sunset Novelties, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Camphor 2%
Menthol 6%
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 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, consult a doctor.
Other Safety Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F
(15°-30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Salicylic Acid, Glycerin, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140).
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