Otc - Active Ingredient
Camphor 2%
Menthol 6%
Menthol, Camphor Gel
FDA Label NDC 72937-006
11 label sections · Submitted to the FDA by Sunset Novelties, Inc · 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, stop use and ask a doctor if:, if pregnant or breast – feeding:, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Uses:
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
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.
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 Safety Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F
(15°-30° C).
Inactive Ingredient
Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) 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 No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).
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