MARCO VITI BORIC ACID 3% OINTMENT
Antiseptic for the disinfection of minor burns and irritated or chapped skin areas. The ointment also has a decongestant action. Boric acid is indicated as an antibacterial for treating acne.
Dosage and method of use
External use: apply as needed on the affected area. Adults: Boric acid can be applied directly once or twice a day to inflamed areas in case of chapped, irritated or dry skin, abrasions, mild burns, sunburns, wind burns or insect bites. Children over 3 years old: Boric acid can be applied directly once or twice a day to inflamed areas associated with chapped, irritated or dry skin, diaper rash, mild sunburn, sunburn, wind burn, or insect bites.
Boric acid is contraindicated in case of: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - extensive skin lesions; - children under 3 years of age.
Absorption of boric acid through intact skin is less than 0.5%; however it may increase if accidentally administered systemically or applied to wounds or lesions. Below are the undesirable effects of boric acid which occurred in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the MedDRA System Organ Class. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders: Dermatitis, skin rashes, alopecia. Gastrointestinal disorders. Gastro-intestinal disorders: nausea, vomiting, diarrhea. Metabolism and nutrition disorders: Anorexia. Endocrine pathologies: Menstrual disorders. Disorders of the blood and lymphatic system: Anemia. Musculoskeletal and connective tissue disorders: Weakness. Psychiatric disorders: Confusion. Nervous system disorders: Convulsions. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
Excessive and prolonged application to large areas or broken skin can cause build-up toxicity. Keep out of reach of children, as deaths have occurred as a result of accidental ingestion. The medicinal product must not be used for ophthalmic use.
Pregnancy and breastfeeding
Pregnancy: No clinical data on exposed pregnancies are available. Animal studies are insufficient to detect effects on embryonic / fetal development (see section 5.3). The potential risk for humans is unknown, however if the medicinal product is used in accordance with the directions for use, absorption is low and the risk of systemic effects is minimal. Feeding time: No data are available on the use of the medicine during breastfeeding and it is not known whether this active substance passes into breast milk. However, as the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach the breast milk.
Expiration and retention
Keep the container tightly closed to protect from light.
Interactions with other drugs
There is no known interaction between boric acid for external use and other medicinal products.
The risk of acute cutaneous intoxication appears negligible given its low transcutaneous absorption index. Boric acid can be absorbed in toxic quantities through the gastrointestinal tract, by inhalation or through skin lesions. Symptoms As a result of the use of large quantities of boric acid on wounds or sores, cases of poisoning and death have occurred, especially in children. The mechanism of the toxic action is unknown and numerous organs and systems are affected, in particular the skin, kidney and digestive tract. The toxic effects also affect the CNS and lung with lesions, mainly haemorrhagic, of obscure origin. The main symptoms of boric acid poisoning are vomiting, diarrhea, visceral pain, peeling skin rash, CNS stimulation followed by depression, restlessness, headache. Metabolic acidosis and severe hydro-saline imbalances are also frequent. Furthermore, boric acid in these situations can cause seizures, changes in body temperature and kidney damage which can be evidenced by oliguria. Death from circulatory collapse and untreated shock can occur within 3-5 days. Cyanosis, delirium, seizures and coma (HSDB) can also occur. Cases of severe intoxication have resulted in gastrointestinal disturbances (73%), on the central nervous system (67%) and skin lesions (76%). Symptoms of chronic poisoning include anorexia, confusion, debilitation, dermatitis, menstrual disorders, anemia, seizures and alopecia (see section 4.8). Treatment No treatment is needed if the dose taken is less than 50 mg / kg. For ingestion of higher doses, gastric lavage is performed with activated charcoal suspension and saline purgative. If the absorbed quantity exceeds 100 mg / kg, even if the patient is still asymptomatic, forced diuresis must be instituted immediately, in order to accelerate elimination and protect the kidney from toxic effects; at the first signs of renal insufficiency and water overdose, forced diuresis should be replaced with peritoneal dialysis or hemodialysis. The remaining therapy is symptomatic and resuscitation.
100 g of ointment contain: active ingredient: boric acid 3 g. For the full list of excipients, see section 6.1.
White petroleum jelly.