SPL v1
SPL
SPL Set ID 3c4bc55d-6582-3b5e-e063-6394a90a994c
Route
TOPICAL
Published
Effective Date 2025-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Glucosamine Sulfate Glyceryl Stearate Stearic Acid Triethanolamine Phenoxyethanol Arnica Montana Dimethyl Sulfone Ethylhexylglycerin Sodium Chondroitin Sulfate (porcine; 5500 Mw) Sodium Polyacrylate (8000 Mw) Peg-100 Stearate Cetearyl Alcohol Isostearyl Palmitate Glycerin Water Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-08

Description

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

Purpose

Topical Analgesic


Medication Information

Warnings and Precautions

For external use only.

Do not used on damaged or broken skin.

Purpose

Topical Analgesic

Dosage and Administration

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.

Description

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

Uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

Section 44425-7

Protect the product in this container from excessive heat and direct sun.

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if

  • rash or irritation develops and lasts
  • condition worsens
  • if symptoms persist more than 7 days or clear up and occur again in a few days.
Section 50567-7

When using this product

  • Avoid contact with the eyes
  • Do not bandage tightly
Section 51727-6

Arnica Montana Extract, Cetearly Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Silica, Sodium Chondroitin Sulfate, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Methyl Salicylate 25%


Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Do not used on damaged or broken skin.

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat and direct sun.

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rash or irritation develops and lasts
  • condition worsens
  • if symptoms persist more than 7 days or clear up and occur again in a few days.
Section 50567-7 (50567-7)

When using this product

  • Avoid contact with the eyes
  • Do not bandage tightly
Section 51727-6 (51727-6)

Arnica Montana Extract, Cetearly Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Silica, Sodium Chondroitin Sulfate, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Methyl Salicylate 25%

Purpose

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

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