FDA Label for Sunset Heating Pain Relief Roll-on
View Indications, Usage & Precautions
Sunset Heating Pain Relief Roll-on 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 ………………………………...…………………………….…. 4%
Otc - Purpose
Topical Analgesic
Use
Aid for temporary local relief of minor pain in muscles and joints.
Warnings
• For external use only. • Ask a doctor
before use if you have redness over affected area.
Otc - When Using
- Avoid contact with the eyes or mucous membranes.
- Do not apply to wounds or damaged skin.
- Do not apply to the irritated skin or if excessive irritation develops.
- Do not bandage.
- Do not use with heating pad or device.
- Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Otc - Pregnancy 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 of age
● 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.
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°F-86° F (15°C-30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow #6 (CI 15985).
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