Finished product reference
Hydroquinone
Cream · Topical · 4 % · 30 g
- List code
- 2006
- Pharmacologic class
- Melanin Synthesis Inhibitor
What it is and how it works
Mechanism class: Melanin Synthesis Inhibitors
Indications
INDICATIONS AND USAGE Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Hydroquinone USP, 4% Skin Bleaching Cream should be applied to affected areas and rubbed in well twice daily, in the morning and before bedtime, or as directed by a physician. If no improvement is seen after 2 months of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.
Contraindications
CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.
Warnings and precautions
WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Storage and supply
Store at 20-25°C (68-77°F) .
Source: Hydroquinone (Hydroquinone 4%) — US FDA prescribing information, 2023-06-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
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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