Methyl Salicylate 25% Cream

Methyl Salicylate 25% Cream
SPL v2
SPL
SPL Set ID 143f76bf-2de4-466a-8a6b-d6ab6314a2c3
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Glycerin Cetostearyl Alcohol Ethylhexylglycerin Glucosamine Sulfate Chondroitin Sulfate (bovine) Glyceryl Monostearate C13-14 Isoparaffin Isostearyl Palmitate Trolamine Stearic Acid Propylene Glycol Laureth-7 Peg-100 Monostearate Water Phenoxyethanol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-14

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Drug Facts

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.

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
Active Ingredient

Methyl Salicylate 25%

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

Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

Manufactured For:

Medcore LLC

3048 Valley Rd.

Basking Ridge, NJ 07920

Questions or Comments Please call

908-280-2269

Principal Display Panel

NDC: 82461-415-10

Medcore LLC

Methyl Salicylate 25% Cream

120mL

Manufactured For:

Medcore LLC

3048 Valley Rd.

Basking Ridge, NJ 07920

Questions or Comments Please call

908-280-2269

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 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 the Reach of Children.

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


Structured Label Content

Drug Facts

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

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 ask a doctor
Active Ingredient (Active ingredient)

Methyl Salicylate 25%

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

Glycerine, CETOSTEARYLALCOHOL, ETHYLHEXYLGLYCERIN, GLUCOSAMINE SULFATE, CHONDROITIN SULFATE, (BOVINE), GLYCERYL MONOSTEARATE, C13-14ISOPARAFFIN, ISOSTEARYL PALMITATE, TROLAMINE, STEARIC ACID, PROPYLENE GLYCOL, LAURETH-7, PEG-100 STEARATE, Water, PHENOXYETHANOL.

Manufactured For:

Medcore LLC

3048 Valley Rd.

Basking Ridge, NJ 07920

Questions or Comments Please call

908-280-2269

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 82461-415-10

Medcore LLC

Methyl Salicylate 25% Cream

120mL

Manufactured For:

Medcore LLC

3048 Valley Rd.

Basking Ridge, NJ 07920

Questions or Comments Please call

908-280-2269

When Using This Product (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 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 the Reach of Children. (Keep out of the reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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