Marco Viti Salicylic Acid 2% Dermatological Ointment 30g

Salicylic acid based ointment.

Therapeutic indications

Salicylic Acid 2% Ointment is used in:

• Treatment of psoriasis, acne vulgaris, seborrhea in adults and children
• Removal of warts and corns in adults and children;
• Local treatment of some forms of eczema and ichthyosis in adults

Dosage and Posology

Salicylic Acid 2% Ointment is administered as follows: apply locally the minimum quantity of ointment in relation to the area to be treated with a light massage. Start the treatment by applying the medicine only on a small portion of the skin or once a day, so as not to irritate the skin.

Overdose

There have been no reports of overdose with locally applied salicylic acid. However, in case of excessive absorption of the active ingredient (eg prolonged application on large areas of the body or on injured and inflamed skin) a state of salicylism could occur. Symptoms of salicilism are: nausea, vomiting, tinnitus (or tinnitus) and dizziness. Rarely, gastric ulcer, asthma, hepatotoxicity, renal failure and pancreatic toxicity can occur.

Contraindications

• Hypersensitivity to the active substance, to salicylates or to any of the excipients (patients hypersensitive to salicylates, such as acetylsalicylic acid, propylsalicylate, bromosalicylic acid, zinc salicylate, may also be hypersensitive to salicylic acid);
• Children under the age of 2
• Diabetes
• Peripheral vascular disease.

Side effects

The following are the side effects of salicylic acid, organized according to the MedDRA systemic classification. Insufficient data are available to establish the frequency of the individual effects listed.

• Metabolism and nutrition disorders
• Hypoglycemia.
• Skin and subcutaneous tissue disorders
• Irritation, dermatitis, burning, itching, erythema, peeling of the skin, scarring on the face.

Pregnancy and breastfeeding

There are no adequate data on the use of salicylic acid in pregnant and lactating women. Therefore, salicylic acid solutions and ointments should not be used during pregnancy and lactation unless absolutely necessary. Studies in animals have shown reproductive toxicity.

While the potential risk for humans is unknown. However, it should be noted that despite being used locally, salicylic acid is absorbed systemically, easily crosses the placenta to find higher concentrations in fetal plasma, and is excreted in breast milk.

Special warnings

The medicine should not be ingested. Salicylic acid is irritating and may cause dermatitis. In the treatment of corns and warts it is necessary to protect the surrounding intact skin to minimize the absorption of the active ingredient

Salicylic acid should not be used for long periods of time, in high concentrations, on large areas of the body, or on injured or inflamed skin, as a
Excessive absorption of the active substance can cause systemic salicylate poisoning (see section 4.9) mainly in children, which can be fatal.

Avoid contact with mouth, eyes, genitals and other mucous membranes. Use with caution in children as experience with the use of salicylic acid in this population is limited. An improvement in the treated skin can be observed after 6 weeks of therapy or after 12 weeks in case of removal of a wart.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition

100 g of Salicylic Acid 2% Ointment contain:

Active principles

Salicylic acid 2 g.

Excipients

White petroleum jelly.