Ben-Gay, cream 50 g

Causes muscle relaxation, increases blood flow, facilitates removal of irritating metabolic products (primarily lactic acid), and also increases the duration of exercise due to the warming effect and improves their portability.

Racetentol

The irritating effect of Racetentol helps reduce pain sensations. Its local action is accompanied by vasodilatation, causing a sensation of cooling that turns into a mild burning and tingling sensation followed by an analgesic effect.

Methyl salicylate

Methyl salicylate is an anti-inflammatory analgesic. Non-selective inhibits cyclooxygenase, reducing the synthesis of prostaglandins. Normalizes increased capillary permeability, improves microcirculation, reduces swelling and infiltration of inflamed tissues.

Indications

• to reduce pain and stiffness in joints and muscles due to injuries, sprains and inflammation

• to reduce pain in the lower back

• for myalgia (muscle pain) before and after sports.

Pharmacological effect

Causes muscle relaxation, increases blood flow, facilitates the removal of irritating metabolic products (primarily lactic acid), and also allows you to increase the duration of physical exercise due to the warming effect and improves their tolerance.

Racementol

The irritating effect of racementol helps reduce pain. The local effect is accompanied by vasodilation, causing a cooling sensation, which turns into a slight burning and tingling sensation, followed by an analgesic effect.

Methyl salicylate

Methyl salicylate is an anti-inflammatory pain reliever. Non-selectively inhibits cyclooxygenase, reducing the synthesis of prostaglandins. Normalizes increased capillary permeability, improves microcirculation processes, reduces swelling and infiltration of inflamed tissues.

Special instructions

For external use only.

Do not use with occlusive dressings or warm compresses. If skin irritation occurs, stop use. Avoid contact with eyes, mucous membranes, and areas of skin irritation. If the pain persists for 10 days or more and the cream does not provide relief, you should consult a doctor.

Cross-allergy to other salicylates is possible.

Do not use in children under 12 years of age!

If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Active ingredient

Methyl salicylate, Racementol

Composition

Active substances:

methyl salicylate – 150 mg;

racementol – 100 mg;

Excipients:

stearic acid – 130 mg,

glyceryl monostearate – 80 mg,

anhydrous lanolin – 20 mg,

sorbitan trioleate (polysorbate 85) – 20 mg,

sorbitan tristearate (span 65) – 10 mg,

trolamine (triethanolamine) – 10 mg,

purified water – 480 mg.

Pregnancy

When entering the systemic circulation, salicylates penetrate the placental barrier and into the milk of nursing women and can adversely affect the fetus, especially in the third trimester of pregnancy (for example, cause premature closure of the ductus arteriosus or prolonged labor).

Despite the fact that with topical use of methyl salicylates, their concentration in the blood plasma is not expected to increase to levels dangerous to the fetus, when deciding on the possibility of prescribing the drug during pregnancy and breastfeeding, the expected benefit of drug therapy for the mother and the potential risk for the fetus and child should be assessed.

Contraindications

• hypersensitivity to any component of the drug
• violation of the integrity of the skin and inflammatory skin diseases at the site of application
• children up to 12 years old
• pregnancy (III trimester).

Side Effects

Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000).

Post-marketing data:

Immune system disorders: angioedema (very rare).

Respiratory, thoracic and mediastinal disorders: dyspnea in the context of hypersensitivity (very rare).

General and administration site conditions: administration site reactions (including blistering, burning, flushing, erythema, irritation, pain, paresthesia, urticaria, itching and rash) (very rare).

Injuries, intoxications and complications of manipulation: burns at the site of application (very rare).

Interaction

The drug causes hyperemia of the skin and reflexively increases blood circulation in the subcutaneous tissue, thus, combined use with other topical drugs can lead to increased absorption.

In patients sensitive to acetylsalicylic acid, skin allergic reactions and angioedema were observed when methyl salicylate was used externally.

When combined with acetylsalicylic acid, toxic effects of salicylates may be observed.

Patients taking anticoagulants such as warfarin may experience bleeding because this drug contains salicylate.

Overdose

Overdose of racementol and methyl salicylate has been observed in isolated cases, mainly in children, due to accidental ingestion of drugs containing these substances.

Overdose for external use occurs rarely and only when the drug is used incorrectly (application to mucous membranes, large areas of damaged or infected skin). Symptoms of an overdose of methyl salicylate: agitation, increased depth of breathing, hyperpyrexia.

Symptoms of racementol overdose: nausea, abdominal pain, vomiting and symptoms of central nervous system depression such as dizziness, unsteady gait, flushing, drowsiness, respiratory depression and coma.

Treatment: symptomatic and supportive; correction of electrolyte and water balance, prescription of adsorbents and saline laxatives, forced diuresis, external cooling of the body; in severe cases – blood transfusion, hemodialysis.

Clinical pharmacology

Pharmacokinetics:

When applied externally, the concentration of racementol in the systemic circulation is insignificant.

When applied externally, methyl salicylate penetrates into tissues through intact skin, while an analgesic concentration in the systemic circulation is not achieved. The effect is local only. Salicylates are excreted mainly by the kidneys; the rate of excretion depends on plasma concentration and urine pH.

Short product description

When entering the systemic circulation, salicylates penetrate the placental barrier and into the milk of nursing women and can adversely affect the fetus, especially in the third trimester of pregnancy (for example, cause premature closure of the ductus arteriosus or prolonged labor). Despite the fact that with topical use of methyl salicylates, their concentration in the blood plasma is not expected to increase to levels dangerous to the fetus, when deciding on the possibility of prescribing the drug during pregnancy and breastfeeding, the expected benefit of drug therapy for the mother and the potential risk for the fetus and child should be assessed.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

2 years.

Manufacturer

JANSSEN-SILAG, France