Each mL of Acne Wash, 2% liquid soap contains:

active ingredient: salicylic acid – 20 mg;

For a full list of excipients, see section List of excipients.

A greenish viscous liquid with an apple odor.

Therapeutic indications

Acne Wash is for the management of acne. It helps prevent new comedones (blackheads and whiteheads) papules and pustules (acne pimples).

For topical administration.

Adults:

Acne Wash is used to wash the affected area 2 to 3 times daily. Lather with warm water, massage into skin, rinse and dry.

Children:

As for adults.

Elderly:

As for adults.

Acne Wash is contraindicated in persons with a sensitivity to salicylic acid.

For external use only. Avoid contact with the mouth, eyes and other mucous membranes to avoid irritation.

As with other topical preparations containing salicylic acid, excessive prolonged use may result in symptoms of salicylism (see section Overdose).

Medicine contains methylparaben which may cause allergic reactions (possibly delayed).

Interaction with other medicinal products and other forms of interaction

None known.

Whilst there are no known contra-indications to use of Acne Wash during pregnancy and lactation, the safety has not been established. Acne Wash should therefore be used with caution or following professional advice.

None known.

Salicylic acid is a mild irritant and may cause skin irritation. If undue skin irritation develops or increases adjust the usage schedule or consult your physician.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Arpimed “LLC” by going to www.arpimed.com and fill out the appropriate form ″Report an adverse reaction or inefficiency of drug″. Hotline number: (+374 55) 05 79 86. And by using Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan ″CJSC ″, going to the site: www.pharm.am in ″Report about adverse effect of medicine″ section and fill out the ″Report of adverse reaction or manufacturing problem of medicinal product″. Hotline numbers: +37410200505; +37496220505.

Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Acne Wash is used as indicated.

Pharmacotherapeutic group: Dermatological drug.

ATC Code: D02AF

Human comedones, naturally or coal tar induced, are firmly anchored and are dislodged with great difficulty. Most classic “peeling” agents are ineffective: they are merely irritants which cause scaling, creating the illusion of comedolysis. While salicylic acid is an irritant its efficacy is dependent on specific pharmacological effects. It seems to detach horny cells from each other by weakening the intercellular cement. As a result, the comedones tend to undergo disorganisation. The effect is probably a good deal more complex. Salicylic acid penetrates skin readily and increases turnover which also favours exfoliation of the comedo. In concentrations of 0.5 to 2% it significantly reduces the formation of microcomedones, which are the precursors of all other acne lesions.

There is no evidence of any systemic absorption from the use of Acne Wash.

None presented.

List of excipients

Cocamidopropyl betaine

Polyquaternium 10

Sodium laureth sulfate

Sodium chloride

Disodium EDTA

Methylparaben

Aroma apple

Color apple green

Water purified

Not applicable.

3 years.

Store at temperature not higher than 20⁰C, in a dry place, out of the reach of children. Protect from light.

100 mL of liquid soap is filled into bottles (inside package).

The bottles are packed and inserted with the leaflet into cardboard box (outer package).

No special requirements.