Methyl Salicylate 25% Cream

Methyl Salicylate 25% Cream
SPL v2
SPL
SPL Set ID 8f0ba6e7-8aa4-443e-99ae-a255085ddfec
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (25 g)
Inactive Ingredients
C13-14 Isoparaffin Cetostearyl Alcohol Chondroitin Sulfate Sodium, Shark Ethylhexylglycerin Glucosamine Sulfate Potassium Chloride Glycerin Glyceryl Monostearate Isostearic Acid Laureth-7 Peg-100 Monostearate Phenoxyethanol Polyacrylamide (1500 Mw) Propylene Glycol Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

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

Purpose

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


Medication Information

Purpose

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

Dosage and Administration

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

Description

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
Section 53413-1

Questions?Call 877-227-3137

Section 55105-1

Warnings

For external use only.

Drug Facts

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, glucosamine 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

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

Box Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

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.

Active Ingredient                                               purpose

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


Structured Label Content

Uses

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

  • simple backache
  • lumbago
  • arthritis
  • neuralgia
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

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

Section 53413-1 (53413-1)

Questions?Call 877-227-3137

Section 55105-1 (55105-1)

Warnings

For external use only.

Drug Facts

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, glucosamine sulfate potassium chloride, glycerin, glyceryl stearate, isostearic acid, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Carton Label

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

Box Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

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 Doctor If (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. (Keep out of reach of children.)

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

Active Ingredient                                               purpose (Active Ingredient                                               Purpose)

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


Advanced Ingredient Data


Raw Label Data

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