FDA Label for Menthol, Camphor
View Indications, Usage & Precautions
Menthol, Camphor 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
Menthol 6%
Camphor 2%
Otc - Purpose
Topical Analgesic
Pain Relieving
Uses:
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
Otc - When Using
WHEN USING THIS PRODUCT:
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.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Stop Use
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 needed, but no more than 3 to 4 times per day.
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.
Inactive Ingredient
Aqua, Alcohol Denat, Propylene Glycol, Salicylic Acid, Glycerin, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Arvensis Herb Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140).
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