Methyl Salicylate 25_percent Pump Cream

Methyl Salicylate 25_percent Pump Cream
SPL v1
SPL
SPL Set ID d8b8b0ba-69e9-4965-bf9b-6db21db69b34
Route
TOPICAL
Published
Effective Date 2024-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Chondroitin Sulfate (bovine) Ethylhexylglycerin Glucosamine Sulfate Glyceryl Monostearate Cetostearyl Alcohol Aloe Vera Leaf C13-14 Isoparaffin Isostearyl Palmitate Trolamine Laureth-7 Peg-100 Stearate Phenoxyethanol Propylene Glycol Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Methyl Salicylate 25 % Pump Bottle Cream   ​Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Methyl Salicylate 25 % Pump Bottle Cream   ​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.

Section 42229-5

Methyl Salicylate 25 % Pump Bottle Cream  

​Drug Facts

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

Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

Methyl Salicylate 25% Pump Bottle Cream

NDC: 50488-1016-5

50 mL

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Tel: 888.495.6078

Principal Display Panel

NDC 50488-1016-5

Methyl Salicylate 25% Pump Bottle Cream

50 mL

Rev 05/24

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.


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.

Section 42229-5 (42229-5)

Methyl Salicylate 25 % Pump Bottle Cream  

​Drug Facts

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 (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 (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

Methyl Salicylate 25% Pump Bottle Cream

NDC: 50488-1016-5

50 mL

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Tel: 888.495.6078

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-1016-5

Methyl Salicylate 25% Pump Bottle Cream

50 mL

Rev 05/24

When Using This Product (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 (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. (Keep out of 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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