SPL v1
SPL
SPL Set ID 2d58c15a-5ddb-1b16-e063-6294a90a3fbb
Route
TOPICAL
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Carbomer 940 Cetyl Alcohol Trolamine Water Stearic Acid Oleth-3 Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28

Description

Menthol - 10% Methyl salicylate - 15%

Purpose

Topical Analgesic Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Description

Menthol - 10% Methyl salicylate - 15%

Uses
  • For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains
Section 50565-1

Keep this and all drugs out of the reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only

Avoid contact with eyes and mucous membranes

  • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not apply bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days.

Directions
  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor.
  • Unless treating hands, wash hands throughly with soap and water immediately after use.
Other Information

Store at controlled room temperature 68°- 77°F ( 20° to 25°C) Close cap tightly afteruse.

Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Inactive Ingredients

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

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Structured Label Content

Uses
  • For temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, bruises and sprains
Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Topical Analgesic

Topical Analgesic

Warnings

For external use only

Avoid contact with eyes and mucous membranes

  • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not apply bandage tightly.
  • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
  • Discontinue use if excessive irritation of skin develops.
  • If pregnant or breast feeding, ask a health professional before use.
  • A temporary burning sensation may occur upon application, but generally disappears in a few days.

Directions
  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age; consult a doctor.
  • Unless treating hands, wash hands throughly with soap and water immediately after use.
Other Information (Other information)

Store at controlled room temperature 68°- 77°F ( 20° to 25°C) Close cap tightly afteruse.

Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Inactive Ingredients (Inactive ingredients)

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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