API

Choline Salicylate (8.7% w/w) + Tannic Acid (10% w/w)

Drug classification

Topical analgesic and anti-inflammatory; salicylate derivative (choline salicylate) and astringent (tannic acid).

Dosage form

Topical cream for external use.

API strength per dosage

Dose

Orex Cream is typically applied thinly to the affected area 2–3 times daily. For both adults and children, avoid prolonged use or application to large areas. Safety in severe renal or hepatic impairment is not established; use with caution. Not for use on broken skin or in children under 2 years unless directed by a physician.

Mechanism of action

Choline salicylate inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation and pain. Tannic acid acts as an astringent by precipitating proteins on mucosal surfaces, forming a protective layer that reduces irritation and exudation. Together, they provide local analgesic, anti-inflammatory, and protective effects.

Indications

Treatment of Mouth ulcers

Side effects

No common side effects seen

Pregnancy category

Safety of topical choline salicylate and tannic acid in pregnancy is not established; avoid use unless clearly needed and benefits outweigh potential risks.

Precautions

Avoid use on broken or inflamed skin, monitor for local irritation or allergic reactions, do not use in children under 16 due to salicylate content, avoid prolonged or excessive application, monitor for signs of salicylate toxicity, avoid contact with eyes and mucous membranes.

Contraindications

Hypersensitivity to salicylates, tannic acid, or any excipients; history of salicylate-induced asthma; active oral ulceration with secondary infection; children with viral infections (risk of Reye’s syndrome); broken or inflamed mucosa.