Menthol sella 1% skin powder - itching and irritation 100 g

Product Description

Skin Powder

Composition:

100 g of powder contain: Active ingredient: Menthol 1 g For the full list of excipients, see section 6.1.

Excipients

Talc

Therapeutic indications

The medicinal product is indicated in the symptomatic treatment of skin rashes due to exanthematous diseases, irritation, including rubbing, itching and burning in case of insect bites, sunburn and burns.

Contraindications

Hypersensitivity to the active ingredient(s) or to any of the excipients. Children up to 30 months of age Children with a history of epilepsy or febrile convulsions.

Dosage

Mentolo Sella 1% cutaneous powder is contraindicated in children up to 30 months of age (see section 4.3). Sprinkle evenly over the affected area 2 or more times a day. The duration of treatment should not exceed 3 days.

Warnings and precautions

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Treatment should not be prolonged for more than 3 days. 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus, and turpentine (due to their lipophilic properties, the rate of metabolism and elimination is unknown) in tissues and the brain, particularly neuropsychological disorders. A dose higher than recommended should not be used to avoid a greater risk of adverse drug reactions and disorders associated with overdose (see section 4.9). The medicine should be used externally only; it should not be inhaled and should not be applied to eyes or mucous membranes. It should not be applied to open wounds or surgical gloves. Menthol Sella 1% cutaneous powder should be used with caution in children up to 6 years of age. Routine use in daily child hygiene is not recommended as inhalation may cause irritation. cause lung irritation with the risk of severe breathing difficulties and death. If it is suspected that the child has inhaled Mentolo Sella 1% cutaneous powder, respiratory function must be carefully monitored because the onset of symptoms may be delayed for several hours. Hemolysis and kernicterus may occur in infants with glucose-6-phosphate dehydrogenase deficiency exposed to menthol. Important information about some excipients Talc: Overuse of nasally administered medications containing talc as an excipient has been reported to cause pulmonary granulomas. Although talc does not cause acute toxicity, fatal cases have been reported following acute exposure to talc. Inhalation of the dust has caused death, primarily in infants. Inhalation of talc causes irritation of the respiratory tract, coughing, shortness of breath, sneezing, vomiting, and cyanosis. The onset of these symptoms may be delayed. occur within 12–24 hours. Acute exposure can cause permanent effects on the lungs. Intense and prolonged exposure to talc can cause pneumoconiosis. When injected intravenously, it can cause retinopathy, emboli, and pulmonary hypertension. Applying talc to open wounds can cause severe granulomatous reactions. Talc is a strong irritant to the eyes and can cause symblepharon, in some cases requiring surgical correction.

Interactions

Mentolo Sella 1% cutaneous powder should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal, or inhalation). No interaction studies have been performed.

Undesirable effects

Due to the presence of menthol and in case of non-compliance with the recommended doses, there may be a risk of convulsions in children and newborns. The following are the undesirable effects of menthol organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the listed effects. Skin and subcutaneous tissue disorders: Contact dermatitis. Cases of umbilical granulomas due to contamination of the umbilical cord residue with talcum powder have been reported.

Pregnancy and breastfeeding

Pregnancy There are no or limited data on the use of menthol in pregnant women. Mentolo Sella 1% cutaneous powder is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. Breastfeeding: There is insufficient information on the excretion of menthol in breast milk. Menthol Sella 1% cutaneous powder should not be used during breastfeeding.