Health Risks and Adverse Effects
- Abuse of Hydroquinone 1-2% can cause serious adverse reactions including convulsions and tremors.
- Hypersensitivity reactions have occasionally been reported.
- Prolonged use may result in irreversible hyperpigmentation known as ochronosis.
- Users are cautioned to avoid falling into the "skin lightener trap," which refers to unsafe skin bleaching practices.
Approved Uses and Restrictions
- Use of Hydroquinone is restricted solely to treatment of pathological hyperpigmentation such as chloasma, melasma, freckles, and lentigines.
- Use of Hydroquinone for cosmetic skin bleaching or its incorporation in skin whitening cosmetics is prohibited and will no longer be approved.
Mandatory Labeling Requirements
- Labels on Hydroquinone products must include the following warnings:
- Usage should not exceed two (2) months.
- Not to be applied on broken skin.
- Not to be used on children under twelve (12) years old.
- Should not be applied to more than 10% of the total body surface.
Compliance and Implementation
- Manufacturers are granted six (6) months from the date of approval to:
- Exhaust existing supplies.
- Reformulate products if necessary.
- Apply for initial registration of Hydroquinone products as drugs.
- The Memorandum Circular takes effect immediately upon issuance on August 15, 1994.
Administrative Authority
- The regulation is enforced under the jurisdiction of the Bureau of Food and Drugs, Department of Health, as evidenced by the signature of Director Quintin L. Kintanar, M.D., Ph.D.