Boric acid 3% - antiseptic cutaneous solution 500 ml

Product Description

Afom

Composition:

100 ml of solution contain Active ingredient: boric acid 3 g. For the full list of excipients, see section 6.1.

Excipients

Purified water.

Therapeutic indications

Antiseptic for the disinfection of minor burns and irritated or chapped skin areas. The solution is also used in the form of local swabs with 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 ingredient 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 daily to inflamed areas associated with 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 daily to inflamed areas associated with chapped, irritated, or dry skin, diaper rash, minor burns, 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 medicinal products.

Undesirable 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 are the undesirable effects of boric acid that occurred in case of accumulation toxicity, after prolonged exposure and following systemic absorption. These effects are organized according to the MedDRA system organ classification. There are insufficient data to establish 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, therefore, the risk of systemic effects is minimal. Breastfeeding: No data are available on the use of the medicinal product during breastfeeding and it is not known whether this active substance passes into breast milk. However, since absorption of the drug may be limited, it is recommended that the mothers of pregnant women should be monitored closely. considered negligible, it is very unlikely that significant quantities reach breast milk.