Acne Wash soap liquid

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

salicylic acid

Διαθέσιμο από:

Arpimed LLC

Φαρμακολογική κατηγορία (ATC):

առկա չէ (D02AF)

INN (Διεθνής Όνομα):

salicylic acid

Δοσολογία:

20mg/ml

Φαρμακοτεχνική μορφή:

soap liquid

Μονάδες σε πακέτο:

plastic container 100ml

Τρόπος διάθεσης:

OTC

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2019-09-19

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC) ACNE WASH 2 % LIQUID SOAP
1.1 BRAND NAME – Acne Wash
1.2 INTERNATIONAL NON-PROPERTY NAME – Salicylic acid
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each mL of Acne Wash, 2% liquid soap contains:
ACTIVE INGREDIENT: salicylic acid - 20 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
A greenish viscous liquid with an apple odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acne Wash is for the management of acne. It helps prevent new
comedones (blackheads and
whiteheads) papules and pustules (acne pimples).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3 CONTRAINDICATIONS
Acne Wash is contraindicated in persons with a sensitivity to
salicylic acid.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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 4.9 Overdose).
_Medicine contains methylparaben which may cause allergic reactions
(possibly delayed). _
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
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.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
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