Methyl Salicylate Cream
FDA Label NDC 85231-201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Violacare, Inc. for the product Methyl Salicylate (NDC 85231-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient                                               purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient                                               Purpose

Methyl Salicylate 25%........................................Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • lumbago
  • arthritis
  • neuralgia
  • strains
  • bruises
  • sprains

Warnings

For external use only.

When Using This Product

  • avoid contact with the eyes
  • do not use in larger quantities, particularly over raw surfaces or blistered areas
  • do not apply to wounds or damaged skin
  • do not bandage

Stop Use And Ask 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.

Other Information

May be applied under occlusive dressing

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

C13-14 isoparaffin, cetearyl alcohol, chondrotin sulfate sodium, Ethylhexylglycerin, glucosamide sulfate potassium chloride, glycerin, glyceryl stearate, isostearic acid, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, water

Principal Display Panel

Methyl Salicylate 25% Cream - NDC 85231-201-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g)

Carton Label

Carton Label (Methyl Salicylate Cream 60g Carton Label)

Carton Label (Methyl Salicylate Cream 60g Carton Label)

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

* Please review the disclaimer below.