Ben-Gay^® Sport (Cream) Instructions for Use

Marketing Authorization Holder

Johnson & Johnson, LLC (Russia)

Manufactured By

Pfizer Ilaclari, Ltd. Sti. (Turkey)

ATC Code

M02AC (Preparations with salicylic acid derivatives)

Active Substances

Methyl salicylate (Ph.Eur. European Pharmacopoeia)

Racementhol (Rec.INN WHO Registered)

Dosage Form

Ben-Gay® Sport

Cream for external use 280 mg+100 mg/1 g: 35 g tube

Dosage Form, Packaging, and Composition

Cream for external use white in color, homogeneous, with a characteristic odor.

Excipients: stearic acid, glycerol monostearate, anhydrous lanolin, sorbitan trioleate (polysorbate 85), sorbitan tristearate (span 65), xanthan gum, potassium hydroxide, purified water.

35 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

A combined drug that has a local anti-inflammatory and analgesic effect.

Indications

Rheumatism (articular and muscular); arthritis; exudative pleurisy; lumbosciatica; radiculitis; myalgias; muscle pain (before and after sports activities).

ICD codes

Dosage Regimen

Apply externally only. Use as a rub on affected areas.

Apply a thin layer of cream to intact skin. Gently massage the area until fully absorbed.

Use 3 to 4 times daily. The frequency of application may be adjusted based on symptom severity.

For muscle pain related to sports, apply before and after physical activity.

Wash hands thoroughly with soap and water immediately after application.

Limit application to affected areas only. Avoid excessive use.

The maximum duration of continuous use is 7 days. If symptoms persist, discontinue use and consult a physician.

Do not apply to large areas of the body. Do not use with occlusive dressings or heating pads.

Adverse Reactions

Local reactions allergic reactions (itching, urticaria, skin rash).

Contraindications

Hypersensitivity; impaired skin integrity; inflammatory skin diseases at the site of intended application; third trimester of pregnancy; breastfeeding period; children under 18 years of age.

With caution

Intolerance to salicylic acid derivatives; first and second trimesters of pregnancy.

Use in Pregnancy and Lactation

Contraindicated in the third trimester of pregnancy and during lactation (breastfeeding). Used in the first and second trimesters of pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus.

Pediatric Use

Use is contraindicated in children under 18 years of age.

Special Precautions

Avoid contact with the conjunctiva and other mucous membranes.

Do not apply to damaged or irritated skin.

Do not use with warming compresses.

Do not use with oral anticoagulants.

Drug Interactions

The drug causes skin hyperemia and reflexively enhances blood circulation in the subcutaneous tissue – concomitant use with other topical drugs may lead to increased absorption.

This drug in large quantities may increase the toxicity of methotrexate.

This drug in large quantities may reduce the therapeutic effect of hypoglycemic agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.