Ointment
Composition:
100 g of ointment contain Active ingredient: boric acid 3 g. For the full list of excipients, see section 6.1.
Excipients
White petrolatum.
Therapeutic indications
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 the treatment of acne.
Contraindications
Boric acid is contraindicated in case of: – Hypersensitivity to the active substance or to any of the excipients; - Extensive skin lesions; - Children under 3 years of age.
Dosage
External use: apply as needed to 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, minor burns, sunburn, windburn or insect bites. Children over 3 years of age Boric acid can be applied directly once or twice a day to inflamed areas in case of chapped, irritated or dry skin, abrasions, minor burns, sunburn, windburn or insect bites. It can be applied directly once or twice daily to inflamed areas associated with chapped, irritated, or dry skin, diaper rash, minor sunburn, sunburn, windburn, or insect bites.
Warnings and Precautions
Excessive and prolonged application to large areas or broken skin may cause accumulation toxicity. Keep out of reach of children, as deaths have occurred following accidental ingestion. The medicine should not be used for ophthalmic purposes.
Interactions
There are no known interactions between external boric acid and other medicines.
Side Effects
The 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. The following adverse reactions to boric acid have been reported in cases of accumulation toxicity, after prolonged exposure, and following systemic absorption. These effects are organized according to the MedDRA system organ class. There are insufficient data to determine the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Dermatitis, rash, alopecia. Gastrointestinal disorders Gastrointestinal disorders: nausea, vomiting, diarrhea. Metabolism and nutrition disorders Anorexia. Endocrine disorders Menstrual disorders. Blood and lymphatic system disorders Anemia. Musculoskeletal and connective tissue disorders Weakness. Psychiatric disorders Confusion. Nervous system disorders Convulsions.
Pregnancy and breastfeeding
Pregnancy No clinical data on exposed pregnancies are available. Animal studies are insufficient to highlight effects on embryonic/foetal development (see section 5.3). The potential risk for humans is unknown, however, if the medicinal product is used according to the instructions for use, absorption is poor and the risk of systemic effects is minimal. Breastfeeding There are no data available on the use of the medicinal product during breastfeeding and it is not known whether the active substance passes into breast milk. However, since absorption of the drug may be considered negligible, it is very unlikely that significant quantities will reach breast milk.
Product Code:FRCM046785
Richiedi info sul prodotto
