FDA Label for Heating Pain Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES:
- WARNINGS
- OTC - WHEN USING
- IF PREGNANT OR BREAST – FEEDING:
- OTC - KEEP OUT OF REACH OF CHILDREN
- STOP USE AND ASK A DOCTOR IF:
- DIRECTIONS:
- INACTIVE INGREDIENT
- SUNSET - HEATING PAIN RELIEF CREAM 4 OZ TUBE
- SUNSET - HEATING PAIN RELIEF CREAM 8 OZ TUBE
- SUNSET - HEATING PAIN RELIEF CREAM SACHET
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.
Uses:
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
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.
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.
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.
Directions:
Adults and Children over 12 years:
Apply a small amount on the area to be.
Massaged in a circular motion, until absorbed.
Repeat as necessary, but no more than 3 to 4 times daily.
Store tightly closed in a dry place at room temperature between 59°-86° F (15°-30° C).
Wash hands with soap and water after use.
Children under 12 years of age: do not use, consult a doctor.
Inactive Ingredient
Aqua, Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow #6 (CI 15985).
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