Anti-Acne

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

salicylic acid, sulfur, zinc oxide

Available from:

Arpimed LLC

INN (International Name):

salicylic acid, sulfur, zinc oxide

Dosage:

20mg/ml+50mg/ml+150mg/ml

Pharmaceutical form:

suspension topical

Prescription type:

OTC

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC) ANTI-ACNE
®
Topical suspension
1. BRAND NAME – Anti-acne
INTERNATIONAL NON-PROPERTY OR GENERIC NAME – Salicylic acid, Sulfur
precipitated, Zinc oxide
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each mL contains:
_ACTIVE INGREDIENTS: _salicylic acid – 20 mg, sulfur precipitated
– 50 mg, zinc oxide – 150 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Topical suspension.
Milky-white colored suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SHAKE WELL BEFORE USE.
Anti-Acne is applied topically for the treatment of acne vulgaris. The
frequency with which
Anti-Acne is applied should be determined by the severity of the acne
and patient response.
Generally, Anti-Acne intended to be applied and left on the skin are
applied to thoroughly
cleansed skin, covering the entire affected area with a thin layer of
the preparation 1–3 times
daily or as directed by a physician. To avoid excessive drying,
therapy generally is initiated with
a single application daily and then the frequency is increased
gradually if necessary.
4.3 CONTRAINDICATIONS

Anti-Acne is contraindicated in patients with hypersensitivity to
ingredients of
preparation.

Children up to age 12 years.
4.4 PRECAUTIONS FOR USE AND SPECIAL WARNINGS
To minimise absorption after topical application salicylic acid should
not be used for prolonged
periods, in high concentrations, on large areas of the body, or on
inflamed or broken skin.
Contact with mouth, eyes, and other mucous membranes should be
avoided; if contact with the
eyes occurs, the affected eyes should be rinsed thoroughly with water.
It should also be used
with care on the extremities of patients with impaired peripheral
circulation or diabetes; caution
has also been suggested for the use of caustic preparations in
patients with significant peripheral
neuropathy.
It should be considered, that skin diseases that occur with hyperemia
and inflammation or