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Methyl salicylate 40 percent - Medication Information

Product NDC Code 50488-6040
Drug Name

Methyl salicylate 40 percent

Type Brand
Active Ingredients
Methyl salicylate 400 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 2668420
Application Number M017
Labeler Name Alexso, Inc
Packages
Package NDC Code Description
50488-6040-6 60 g in 1 bottle (50488-6040-6)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Methyl Salicylate 40%

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 of age: consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, 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, Polysorbate-20, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine Methyl Salicylate 40 % Cream NDC: 50488-6040-6 6 0 gram Manufactured for: Alexso, Inc 2317 Cotner Ave 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, 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 40 Percent Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID ALOE VERA LEAF WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE LAURETH-7 PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL STEARIC ACID TROLAMINE

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 50488-6040-6 Methyl Salicylate 40% Cream Net Wt. 2 oz. 60 g Rev 10/23 PRINCIPAL DISPLAY PANEL NDC 50488-6040-6 Methyl Salicylate 40% Cream Net Wt. 2 oz. 60 g Rev 10/23

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 40 % Cream Alexso, Inc ---------- Methyl Salicylate 40 % 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