Title
Reclassification of Hydroquinone 1-2% as Drug
Law
Bfad (doh) Memorandum Circular No. 19
Decision Date
Aug 15, 1994
The Bureau of Food and Drugs reclassifies Hydroquinone 1-2% from cosmetics to drugs due to serious health risks, restricting its use to specific medical conditions and prohibiting its application for skin bleaching.
A

Q&A (BFAD MEMORANDUM CIRCULAR NO. 19)

Hydroquinone 1-2% Solution was reclassified from cosmetics to drugs.

Serious adverse reactions include convulsion and tremors, as well as occasional hypersensitivity reactions.

Prolonged use may produce hyperpigmentation known as ochronosis, which is irreversible.

Hydroquinone use is restricted to pathological hyperpigmentation such as chloasma, melasma, freckles, and lentigines.

No, its use for skin bleaching and incorporation in cosmetics for skin whitening is no longer approved.

Warnings include: not to be used longer than two months; not to be applied on broken skin; not to be used on children under 12 years old; and not to treat more than 10% of total body surface.

Hydroquinone should not be used longer than two (2) months.

Yes, it should not be used on children under twelve (12) years of age.

Manufacturers are given six (6) months from the approval date to exhaust existing supplies, reformulate, or apply for initial registration of Hydroquinone as Drugs.

The memorandum circular took effect immediately upon adoption on August 15, 1994.


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