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| Product NDC Code | 68788-7925 | ||||
|---|---|---|---|---|---|
| Drug Name | Methyl salicylate |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 238542 | ||||
| Application Number | part348 | ||||
| Labeler Name | Preferred Pharmaceuticals Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Methyl Salicylate 25%
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 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine Methyl Salicylate 25% Cream NDC: 68788-7925-1 120 grams Manufactured for: Alexso, Inc Los Angeles, CA 90064
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.Uses For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Methyl Salicylate Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE LAURETH-7 DIMETHYL SULFONE PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL STEARIC ACID TROLAMINE CHONDROITIN SULFATE (BOVINE) SODIUM POLYACRYLATE (8000 MW) POLYACRYLAMIDE (10000 MW)
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.PRINCIPAL DISPLAY PANEL NDC 68788-7925-1 Methyl Salicylate 25% Cream 120 grams Relabeled By: Preferred Pharmaceuticals Inc. Methyl Salicylate 25% Cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Methyl Salicylate 25% Cream Alexso, Inc ---------- Methyl Salicylate 25% Cream Drug Facts
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.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase
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.When using this product • Avoid contact with the eyes • Do not use in large quantities, particularly over raw surfaces or blistered areas • Do not apply to wounds or damaged skin • Do not bandage
Storage and handling
Information about safe storage and handling of the drug product.Other information • May be applied under occlusive dressing. • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
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.Warnings For external use only. When using this product • Avoid contact with the eyes • Do not use in large quantities, particularly over raw surfaces or blistered areas • Do not apply to wounds or damaged skin • Do not bandage Stop use and ask a doctor if • allergic reaction occurs • condition worsens or does not improve within 7 days • symptoms clear up and return within a few days • redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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