OLIVIA QUIDO BLEMISH ERASER

5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity If anaphylaxis, asthma or other clinically significantly hypersensitivity reactions occur, institute appropriate therapy and discontinue BLEMISH ERASER. Allergic contact dermatitis may also occur. Since this product contains no sunscreen, an effective broad spectrum sun blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. 5.2 Exogenous Ochronosis BLEMISH ERASER contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. Most patients developing this condition are Black, but it may also occur in Caucasians and Hispanics. 5.3. Effects on Endocrine System Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while treatment. If HPA axis suppression is noted, the use of BLEMISH ERASER should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids. 5.4 Cutaneous Reactions BLEMISH ERASER contains hydroquinone that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, discontinue use of the medication and call a doctor. Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on BLEMISH ERASER treatment. Avoid use of medications that are known to be photosensitizing. If anaphylaxis, asthma or other clinically significantly hypersensitivity reactions occur, institute appropriate therapy and discontinue BLEMISH ERASER. Allergic contact dermatitis may also occur. (5.1) BLEMISH ERASER contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. (5.2)

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately. In case of adverse reaction, call a doctor. (6) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.