XORLYX 2 Salicylic Acid 2% ww Ointment

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SALICYLIC ACID

Available from:

Xorix Sdn Bhd

INN (International Name):

SALICYLIC ACID

Units in package:

15gm mcg/mL; 30gm mcg/mL; 50gm mcg/mL

Manufactured by:

Xorix Sdn Bhd

Summary of Product characteristics

XORLYX 2
_XORLYX 2 SALICYLIC ACID 2% W/W OINTMENT _
_DESCRIPTION_
_XORLYX 2 Salicylic Acid 2% w/w is a white or almost white and
translucent _
_ointment. The ointment is used as a keratoliytic agent._
_XORLYX 2 Salicylic Acid 2% w/w ointment is packaged in a printed
aluminium tube _
_with standard white cap._
_INDICATIONS_
_XORLYX 2 Salicylic Acid 2% w/w Ointment is indicated to alleviate
hyperkeratotic _
_and scaling skin conditions such as seborrhoeic dermatitis,
ichtyosis, psoriasis and _
_acne._
_DOSAGE & ADMINISTRATION_
_Apply sparingly to the affected skin areas twice daily, in the
morning and at night _
_until improvement occurs. Subsequently, it may then be possible to
maintain _
_improvement by less frequent application. _
_CONTRAINDICATIONS_
_• _
_Unknown._
_WARNINGS AND PRECAUTIONS_
_• _
_Avoid broken skin._
_• _
_For external use only._
_• _
_Avoid contact with mouth, eyes and mucous membranes._
_• _
_If irritation or sensitization develops, discontinue treatment._
_• _
_If large areas of skin are treated, the systemic absorption of
topical Salicylic _
_Acid will be enhanced and may lead to Salicylate toxicity._
_• _
_When using salicylic acid preparations do not use any of the
following _
_preparations on the affected area, unless directed to do so by your
doctor; _
_* Any other medicated topical agents, e.g. benzoyl peroxide, topical
retinoids._
_* Abrasive soaps and cleansers. _
_* Cosmetics or soaps that dry the skin or are designed to
peel/exfoliate._
_• _
_Salicylic acid may cause dermatitis. Extensive prolonged use of
topical _
_Salicylic Acid may enhance the systemic absorption and may lead to _
_Salicylate toxicity._
_ _
_Pregnancy and breastfeeding: The safety has not been established. _
_Therefore, it should be used with caution or following professional
advice._
_SIDE EFFECTS / ADVERSE REACTIONS_
_• _
_Contact dermatitis or skin irritation; flushing; unusually warm
skin._
_• _
_Excessive drying and peeling of skin._
_INTERACTION WITH OTHER MEDICAMENTS_
_Other topical pr