HYDROQUINONE: 277 Adverse Event Reports & Safety Profile

DESCRIPTION Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11. The structural formula is: Each gram of Pigment Control Creme (Hydroquinone USP, 4%) contains Hydroquinone USP 40 mg/gm in a base of Purified Water, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam)

Root

Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Chemical

Structure

DESCRIPTION Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11. The structural formula is: Each gram of Pigment Control + Blending Creme contains Hydroquinone USP 40mg/gm in a base of Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam)

Root

Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Purified Water, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Chemical

Structure

INDICATIONS AND 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)

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. 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.

CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Contraindications

Prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Adverse Reactions The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Adverse Reactions

The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

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)

PRECAUTIONS Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

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. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing

Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Precautions

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

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. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing

Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

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.

Active Ingredient Hydroquinone (2%)

Inactive Ingredients Inactive Ingredients• Water, Mineral Oil, Propylene Glycol, Glyceryl Stearate, PEG-10O Stearate, Vitis Vinifera (Grape Seed)

Seed

Oil, Cetyl Alcohol, Emulsifying Wax, Caprylic/Capric Triglyceride, Retinyl Propionate, Kojic Acid, EthylhexylDimethyl PABA, Dimethicone, HydrolyzedOat Protein, Aloe Barbadensis Leaf Juice, Polyacrylamide, C13-14 isoparaffin, Laureth-7, Xanthan Gum, Sodium Hydroxide, Sodium Metabisulfite, Sodium Bisullte, Phenoxyethanol, Ethylhexylglycerin