Boric Acid ALMUS 3%

Skin Solution

Composition:

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

Excipients

Ointment: white petroleum jelly. Skin solution: sodium benzoate, methyl parahydroxybenzoate; ethyl parahydroxybenzote, propyl parahydroxybenzoate, sodium hydroxide, propylene glycol, purified water.

Therapeutic indications

Antiseptic for the disinfection of minor burns and irritated or chapped skin areas. The ointment also has a decongestant action. The solution is also used in the form of local buffers with a decongestant action. Boric acid is indicated as an antibacterial for treating 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 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 sunburn, sunburn, windburn or insect bites. Children over the age of 3 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 .

Warnings and Precautions

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. Important information about some of the ingredients. Boric Acid Almus 3% cutaneous solution contains sodium benzoate, which is slightly irritating to the skin, eyes and mucous membranes; methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, which can cause allergic reactions (even delayed) and, exceptionally, bronchospasm; propylene glycol which can cause skin irritation.

Interactions

There are no known interactions between boric acid for external use and other medicinal products.

Side effects

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 Class. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Dermatitis, rash, alopecia. Gastrointestinal disorders Gastro-intestinal 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 detect effects on embryonic / fetal development (see section 5.3). The potential risk for humans is unknown, however if the medicine is used in accordance with the directions for use, the absorption is low and therefore the risk of systemic effects is minimal. Breastfeeding There are no data on the use of the medicinal product during breastfeeding and it is not known whether this active ingredient 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.