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 10%
Camphor 3%
Menthol 10%
Campor 3%
Otc - Purpose
Menthol 10%……………………………… PURPOSE: External Analgesic
Camphor 3% .......................................... PURPOSE: Pain Relieving
Menthol 10%………………………………………. PURPOSE: External Analgesic
Camphor 3% .......................................... PURPOSE: Pain Relieving
Uses:
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.
For the temporary relief of minor aches and pains of muscles associated with menstrual cycles.
Warnings
Use only as directed.
For external use only.
Do not bandage tightly. Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
Keep away from children. Package not child resistant.
In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to the product, consult to a doctor before using.
Use only as directed.
For external use only.
Do not bandage tightly. Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
Keep away from children. Package not child resistant.
In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to the product, consult to a doctor before using.
Otc - Keep Out Of Reach Of Children
Keep away from children. Package not child resistant.
Keep away from children. Package not child resistant.
Otc - When Using
Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin.
Do not apply on nose and genital area.
If rash, redness or itchiness results; discontinue use and consult a doctor.
Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin.
Do not apply on nose and genital area.
If rash, redness or itchiness results; discontinue use and consult a doctor.
Directions:
Apply a small amount on desired area
Massage in circular motions until absorbed
Repeat as needed but no more than 3 to 4 times per day.
Store tighly closed in a dry place at room temperature between 59°-86°F (15°-30°C).
Wash hands with soap and water after use.
Apply a small amount on desired area
Massage in circular motions until absorbed
Repeat as needed but no more than 3 to 4 times per day.
Store tighly 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, Paraffinum Liquidum, Alcohol Denat., Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Parfum, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Yellow #5 (CI 19140), Geraniol, Citronellol, Hydroxycitronnellal, Linalool, Coumarin.
Aqua, Paraffinum Liquidum, Alcohol Denat., Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Parfum, Stearyl Alcohol, Polysorbate 20, Triethanolamine, Anthemis Nobilis (Chamomile) Flower Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Lavandula Angustifolia Oil, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, D&C Violet # 2 (CI 60730).
* Please review the disclaimer below.