Finished product reference
Fluocinolone / Hydroquinone / Tretinoin
Cream · Topical · 0.01 %/4 %/0.05 % · 15 g
- List code
- 52014
- Pharmacologic class
- Topical depigmenting combination (triple combination cream): corticosteroid, melanin synthesis inhibitor and retinoid
What it is and how it works
Hydroquinone inhibits tyrosinase and so reduces melanin production; tretinoin increases epidermal turnover, enhances hydroquinone penetration and disperses melanin granules; fluocinolone acetonide, a corticosteroid, reduces irritation from the other components and suppresses melanocyte activity. Together they lighten hyperpigmented skin.
Indications
Short-term treatment of moderate to severe facial melasma, used together with sun avoidance and sunscreen.
Dosage and administration (summary)
Topical, a thin film applied once daily at night to the affected areas at least 30 minutes before bedtime, usually for up to 8 weeks; it is not intended for continuous long-term use.
Contraindications
Pregnancy, hypersensitivity to any component, and use on broken, eczematous or sunburnt skin.
Warnings and precautions
Local irritation, erythema, peeling, burning and dryness are common; strict sun protection is needed because tretinoin increases photosensitivity. Hydroquinone may rarely cause exogenous ochronosis (blue-black discolouration), and prolonged corticosteroid use can cause skin atrophy, telangiectasia and rosacea-like eruptions; contact with eyes, mouth and mucous membranes should be avoided.
Pregnancy
Contraindicated in pregnancy because of the retinoid component.
Storage and supply
Store below 25 °C; do not freeze; keep the tube tightly closed.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
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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