Otc - Active Ingredient
Menthol 6%
Camphor 2%
Menthol, Camphor Gel
FDA Label NDC 72937-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunset Novelties, Inc for the product Menthol, Camphor (NDC 72937-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Menthol 6% Topical Analgesic
Camphor 2% Pain Relieving
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
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.
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:
Apply a small amount on desired area.
Massage 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 controlled 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, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140).
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