FDA Label for Heating Pain Relief
View Indications, Usage & Precautions
Heating 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
Methyl Salicylate 18%
Menthol 10%
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
If you experience an allergic reaction, discontinue use and consult a doctor.
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 consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Water (Aqua), Paraffinum Liquidum, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Glycereth-26, Dimethicone, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabis Sativa (Hemp) Seed Oil, Phenoxyethanol, FD&C Yellow No.6 (CI 15985).
Sunset - Heating Pain Relief Cream 4 Fl Oz Tube
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