Finished product reference

Monobenzone

Cream · Topical · 20 % · 30 g

List code
864
Pharmacologic class
Depigmenting agent (melanocytotoxic)

What it is and how it works

Monobenzone (monobenzyl ether of hydroquinone) is converted by tyrosinase into reactive quinones that destroy melanocytes and trigger an immune response against them, producing permanent depigmentation, including at distant sites.

Indications

Permanent depigmentation of remaining normally pigmented skin in patients with extensive, disfiguring vitiligo (typically more than about 50% of body surface).

Dosage and administration (summary)

Topical cream applied thinly to pigmented areas two to three times daily under specialist supervision; depigmentation usually takes several months.

Contraindications

Hypersensitivity; not to be used for melasma, freckles, post-inflammatory hyperpigmentation or other cosmetic hyperpigmentation.

Warnings and precautions

Depigmentation is irreversible and may occur at sites distant from application. Irritation and allergic contact dermatitis may occur. Depigmented skin is highly sensitive to sunlight and must be protected.

Pregnancy

Safety in pregnancy has not been established.

Storage and supply

Store below 25 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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