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| Product NDC Code | 72937-004 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | SUNSET PAIN RELIEF ROLL-ON 3OZ | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Menthol 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS Adults and Children over 12 years Apply a small amount to 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Alcohol Denat, Glycerin, Ceteareth-25, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Sodium Hydroxide, Carbomer, Cannabidiol, Methyl Salicylate.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE Aid for temporary local relief of minor pain in muscles or joints.
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.MENTHOL MENTHOL ALCOHOL CANNABIDIOL SALICYLIC ACID MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM GLYCERIN CARBOMER 940 SORBIC ACID SODIUM HYDROXIDE BENZYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES CALENDULA OFFICINALIS FLOWER METHYL SALICYLATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.SUNSET PAIN RELIEF +350 CBD ROLL-ON sunset roll on gold
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If swallowed, get medical help, or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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. If you experience an allergic reaction, discontinue use and consult a doctor. Do not expose the area treated with product to heat or direct sunlight.
Pregnancy or breast feeding
Pregnancy or Breast feedingAsk a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only. · Ask a doctor before use if you have redness over affected area
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API