Methyl Salicylate 25% Cream

Methyl Salicylate 25% Cream
SPL v1
SPL
SPL Set ID 32c153c7-de30-504e-e063-6294a90a4020
Route
CUTANEOUS
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Xanthan Gum Mineral Oil Peppermint Oil White Petrolatum Aloe Barbadensis Leaf Glyceryl Stearate Se Cetyl Alcohol Propylene Glycol Peg-100 Stearate Water Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-15

Description

Methyl Salicylate 25%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Methyl Salicylate 25%

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

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

MANUFACTURED FOR:

Marcella Health

Cheyene, WY 82001

Questions or Comments

(307) 410-3813 or [email protected]

Principal Display Panel

Drug Facts:

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

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

External 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

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

MANUFACTURED FOR:

Marcella Health

Cheyene, WY 82001

Questions or Comments

(307) 410-3813 or [email protected]

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Drug Facts:

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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