Keep out of reach of children. Read this package insert carefully before use.

1. Ingredients:

2. Pharmaceutical form:

Topical, transparent, reddish brown solution

3. Indications: Treatment of ringworm and fungal skin infection.

4.  Administration, dosage:

4.1. Dosage: Apply 2-3 times per day.

4.2. Admistration:

Topical. Clean the infected skin, then apply the medication.

5. Contraindications:

Hypersensitivity to any ingredients of this product

Do not apply on eyes.

6. Warnings and precautions for use:

There are no report about cases in which precaution for use is required.

7. Pregnancy and lactation:

Not recommended for pregnant women and lactating women. Use only with a doctor’s prescription.

8. Effects on ability to drive, operate machinery:

There is no evidence on the effect of the drug on the ability to drive and use machines.

9. Interactions, incompatabilties with other drugs

Interactions: None reported

In absence of incompatabilities studies, this drug must not be mixed with other drugs.

10. Adverse effects:

– Salicylic acid: Prolonged use of salicylic acid can cause salicylate poisoning (with the following symptoms: confusion, dizziness, severe or constant headache, rapid breathing, vibrations or ringing in the ears continuously).

Common, ADR > 1/100: Mild irritation on skin, burning sensation.

Rare, 1/1000 < ADR < 1/100: moderate to severe skin irritation. Ulcer or skin corrosion, especially when using salicylic preparations at  high concentrations.

Treatment of ADR:

In order to minimize dermal absorption, it is necessary to avoid prolonged, high-dose, widespread application, application on inflamed or damaged skin. In case of contact with eyes, nose, mucous membranes, wash immediately with clean water for 15 minutes. Wash your hands immediately after applying the medicine, unless you have to apply it on your hands. Paraffin oil can be applied to healthy skin to protect the healthy skin from irritation.

– Acid benzoic, Iod: No information about the  topical medication

11. Overdosage and treatment:

11.1. Overdosage:

No data are reported yet, do not use more than the dose indicated.

11.2. Treatment:

Perform intensive monitoring of the patients for prompt treatment.

12. Pharmadynamic properties:

– Salicylic acid:

Salicylic acid exfoliates the keratin layer and gently disinfects skin when it is applied, so it has been used to treat some hyperkeratosis and peeling skin conditions such as seborrheic dermatitis, psoriasis, dandruff. , acne, rice seeds, bottoms of the feet, … depending on the concentration of the drug. At low concentrations, the drug has a keratinizing effect (adjusts the abnormal keratinization process), at high concentrations (≥ 1%), the drug has the effect of exfoliating the keratin layer. Salicylic acid softens and destroys the stratum corneum by increasing endogenous hydration (increasing the concentration of water), possibly by lowering the pH, causing the keratinized epithelial layer to swell, then slough off. The drug has a weak antifungal effect, by removing the keratin layer that prevents the fungus from growing and helping the antifungal drugs to penetrate the skin, so it is also used to treat some fungal skin conditions.

– Acid benzoic, Iod: No information about the  topical medication

13. Pharmacokinetic properties:

– Salicylic acid is easily absorbed through the skin and excreted slowly in the urine, so there have been cases of acute salicylate poisoning due to excessive application of salicylic acid on large skin area.

– Acid benzoic, Iod:  No information about the  topical medication

14. Packaging:

Bottle of 20 ml, 30 ml

15. Storage condition, shelf life, specification:

– Storage condition: store in a dry place, protect from direct light. Do not store above 30^oC

– Shelf life: 36 months since the manufacturing date

– Specification: In house