Methyl Salicylate 40 Percent Cream

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (400 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-01

Medication Information

Purpose

Topical analgesic

Description

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

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, strains, bruises, and sprains.

Section 42229-5

Methyl Salicylate 40 % Cream

Alexso, Inc

----------

Methyl Salicylate 40 % Cream

Drug Facts

Warnings

For external use only.

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

Active Ingredient

Methyl Salicylate 40%

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.

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

Principal Display Panel

NDC 50488-6040-6

Methyl Salicylate 40% Cream

Net Wt. 2 oz. 60 g

Rev 10/23

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.

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, strains, bruises, and sprains.

Section 42229-5 (42229-5)

Methyl Salicylate 40 % Cream

Alexso, Inc

----------

Methyl Salicylate 40 % Cream

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only.

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

Active Ingredient (Active ingredient)

Methyl Salicylate 40%

Other Information (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.

Inactive Ingredients (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-6040-6

Methyl Salicylate 40% Cream

Net Wt. 2 oz. 60 g

Rev 10/23

When Using This 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

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "INDIAN FRANKINCENSE", "unii": "4PW41QCO2M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLUCOSAMINE SULFATE", "unii": "1FW7WLR731", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C13-14 ISOPARAFFIN", "unii": "E4F12ROE70", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOSTEARYL PALMITATE", "unii": "9EHU0R7ER1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURETH-7", "unii": "Z95S6G8201", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, strains, bruises, and sprains.", "42229-5": "Methyl Salicylate 40 % Cream Alexso, Inc ---------- Methyl Salicylate 40 % Cream Drug Facts", "Purpose": "Topical analgesic", "Warnings": "For external use only.", "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", "Active ingredient": "Methyl Salicylate 40%", "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.", "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", "PRINCIPAL DISPLAY PANEL": "NDC 50488-6040-6 Methyl Salicylate 40% Cream Net Wt. 2 oz. 60 g Rev 10/23", "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."}

Methyl Salicylate 40 Percent Cream

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information