Biofreeze (Gel) Instructions for Use

Marketing Authorization Holder

Performance Health, LLC (USA)

Manufactured By

Span Packaging Services, LLC (USA)

ATC Code

M02AX10 (Other drugs)

Active Substances

Camphor (Ph.Eur. European Pharmacopoeia)

Levomenthol (Rec.INN WHO Registered)

Dosage Form

Biofreeze

Gel for external use 3.5 g+0.2 g/100 g: sachets 5 g 100 pcs., tubes 30 g, 55 g or 110 g, bottles 452 g

Dosage Form, Packaging, and Composition

Gel for external use transparent, blue-green or green in color, with a menthol odor.

Excipients: Ilex paraguariensis extract – 5 g, isopropanol – 35 g, carbomer – 0.7 g, trolamine (triethanolamine) – 0.65 g, silicon dioxide – 0.2 g, methylparahydroxybenzoate (methylparaben) – 0.1 g, propylene glycol – 0.01 g, glycerol (glycerin) – 0.01 g, riboflavin – 0.01 g, brilliant blue dye – 0.01 g, deionized water – 54.61 g.

5 g – sachets (100) – cardboard boxes.
30 g – plastic tubes (1) – cardboard boxes.
55 g – plastic tubes (1) – cardboard boxes.
110 g – plastic tubes (1) – cardboard boxes.
452 g – bottles (1) with a pump dispenser – cardboard boxes.

Clinical-Pharmacological Group

Analgesic and local anesthetic agent for external use

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A combined agent of natural origin; exerts a locally irritating (“counterirritant”), mild local anesthetic effect.

Indications

• As a “counterirritant” agent for arthralgia (joint pain), myalgia, sciatica, radiculitis, myositis.

ICD codes

Dosage Regimen

Apply the gel externally only.

Use a quantity of 2 to 3 grams per application for adults.

Apply the gel directly to the painful area of skin.

Rub it in thoroughly using light, massaging movements until fully absorbed.

Repeat the application three to four times daily, depending on the intensity of pain.

Do not apply to broken skin, wounds, or near mucous membranes.

Avoid contact with eyes; if contact occurs, rinse immediately with water.

Do not use a tight bandage or occlusive dressing over the application site.

Do not use concurrently with other topical medications on the same area.

The average treatment course is 10 days.

Adjust the duration of therapy based on the severity and nature of the condition.

Discontinue use and consult a physician if pain persists, worsens, or if skin irritation occurs.

Adverse Reactions

Possible skin itching, skin irritation at the application sites, allergic reactions.

If side effects occur, the use of the drug should be discontinued and a doctor should be consulted.

Contraindications

• Hypersensitivity to the components of the drug;
• Dermatological diseases;
• Impaired integrity of the skin at the intended application sites;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

The gel should be used for external use only!

Avoid contact of the gel with eyes, mucous membranes, wounds, and affected skin areas.

The gel should not be used simultaneously with other topical medicinal products (ointments, creams, sprays, liniments).

A tight bandage should not be applied when using the drug.

Effect on the ability to drive vehicles and operate machinery

No effect.

Overdose

To date, no cases of overdose with the use of the drug have been reported.

Drug Interactions

Not described.

Storage Conditions

Keep away from heat sources and open flame at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 3 years.

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.