Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED BLEMISH ERASER is light yellow in color, and supplied in 48 g jar, NDC 71421-801-30.; BECR
- 16 HOW SUPPLIED BLEMISH ERASER is light yellow in color, and supplied in 48 g jar, NDC 71421-801-30.
- BECR
Overview
BLEMISH ERASER contains 2% of hydroquinone, USP, in a cream base for topical application. Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C6H6O2 and molecular weight is 110.11. Hydroquinone has the following structural formula: BLEMISH ERASER contains Active: 2% (20 mg) Hydroquinone. Inactive: 4-Butylresorcinol, Aloe Barbadensis Leaf Juice, BHT, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Ceramide-NP, Cetyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Citric Acid, Diazolidinyl Urea, Dimethyl Isosorbide, Glycerin, Hexyl Laurate, Iodopropynyl Butylcarbamate, Kojic Acid, Laureth-23, Laureth-7, Maltodextrin, Phenoxyethanol, Polyacrylamide, Polyglyceryl-4 Isostearate, Polysorbate 20, Retinol, Silica, Sodium Hyaluronate, Sodium Hydroxide, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Trideceth-6 Phosphate, Triethylene Glycol, Water/Aqua.
Indications & Usage
1.1Indication BLEMISH ERASER is a combination of hydrocortisone (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and a tretinoin (a retinoid) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. 1.2 Limitations of Use The safety and efficacy of BLEMISH ERASER in pregnant women and nursing mothers have not been established. BLEMISH ERASER is a hydroquinone (a melanin synthesis inhibitor) that is indicated for the gradual bleaching of hyperpigmented skin conditions age and liver spots, freckles, and other unwanted areas of melanin hyperpigmentation, in the presence of measures for sun avoidance, including the use of sunscreen. (1)
Dosage & Administration
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of BLEMISH ERASER to the affected area once daily at night or as directed by a doctor. During the day, use O Skin Sunscreen SPF-50, and wear protective clothing. Avoid sunlight exposure to prevent repigmentation. BLEMISH ERASER is for topical use only. It is not for oral, ophthalmic, or intravaginal use. 2 DOSAGE AND ADMINISTRATION Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of BLEMISH ERASER to the affected area once daily at night or as directed by a doctor. During the day, use O Skin Sunscreen SPF-50, and wear protective clothing. Avoid sunlight exposure to prevent repigmentation. BLEMISH ERASER is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Warnings & 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)
Contraindications
BLEMISH ERASER is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.. (4) BLEMISH ERASER is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.. (4)
Adverse Reactions
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.
Drug Interactions
Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolytic drugs while on BLEMISH ERASER Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Storage & Handling
Storage: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) away from direct sunlight. KEEP REFRIGERATED.
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