Methyl Salicylate: Package Insert and Label Information

METHYL SALICYLATE- methyl salicylate cream
Alexso, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Methyl Salicylate 25 % Cream
Alexso , Inc

Methyl Salicylate 25 % Cream

​Drug Facts

Active ingredient

Methyl Salicylate 25%

Purpose

Topical analgesic

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.

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.

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

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

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: 50488-1015-5

50 grams

Methyl Salicylate 25 % Cream

NDC: 50488-1015-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

PRINCIPAL DISPLAY PANEL

NDC 50488-1015-1
Methyl Salicylate 25% Cream
120 grams

PRINCIPAL DISPLAY PANEL
NDC 50488-1015-1
Methyl Salicylate 25% Cream
120 grams
(click image for full-size original)

Principal Display Panel

NDC 50488-1015-5
Methyl Salicylate 25% Cream
50 grams

NDC 50488-1015-5
Methyl Salicylate 25% Cream
50 grams
(click image for full-size original)
METHYL SALICYLATE
methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-1015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 250 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-1015-1 120 g in 1 BOTTLE None
2 NDC:50488-1015-5 50 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/01/2019
Labeler — Alexso, Inc (963338061)

Revised: 01/2022 Alexso, Inc

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.