appears Obagi-C Rx System Generic Name: hydroquinone Dosage Form: cream Side Effects Dosage Professional Pregnancy Reviews More Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. WELCOME TO THE OBAGI-C RX SYSTEM OF SKIN CARE PRODUCTS! PATIENT INFORMATION For Topical Use Only Complete skin care regimen formulated with 4% hydroquinone to reduce hyperpigmentation and other essential ingredients to help address the signs of skin aging caused by photoaging. Please read this product information prior to use of the Obagi-C Rx System. Any questions regarding your particular skin care regimen should be directed to your physician. More information about the Obagi-C Rx System or other Obagi systems is available at our website at www.obagi.com. Slideshow A Joint Effort: A Provider's Guide To Orthopedic Pain Options PHYSICIAN PRESCRIBING INFORMATION Rx only FOR EXTERNAL USE ONLY 62032-106-10 Obagi-C Rx System C-Clarifying Serum for Normal to Dry Skin Each gram of Obagi-C Rx System C-Clarifying Serum for Normal to Dry Skin contains: Active: Hydroquinone, USP 4% (40 mg per g) Inactives: ascorbic acid, propylene carbonate, propylene glycol, sodium lauryl sulfate, water 62032-122-10 Obagi-C Rx System C-Clarifying Serum for Normal to Oily Skin Each gram of Obagi-C Rx System C-Clarifying Serum for Normal to Oily Skin contains: Active: Hydroquinone, USP 4% (40 mg per g) Inactives: ascorbic acid, dipropylene glycol, fragrance, propylene carbonate, propylene glycol, SD alcohol-39-C, sodium lauryl sulfate, water 62032-105-36 Obagi-C Rx System C-Therapy Night Cream Each gram of Obagi-C Rx System C-Therapy Night Cream contains: Active: Hydroquinone, USP 4% (40 mg per g) Inactives: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water Description Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g per mol. The chemical structure is in the diagram. Obagi-C Rx System - Clinical Pharmacology Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunscreen agents contained in the Obagi-C Rx System Sun Shield Matte Broad Spectrum SPF 50. Indications and Usage for Obagi-C Rx System The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Obagi-C Rx System Dosage and Administration A thin application should be applied once or twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring. Warnings Hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. Close patient supervision is recommended. Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, the patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The Obagi-C Rx System C-Therapy Night Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Precautions (See WARNINGS . ) Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated. Nursing Mothers It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. Pediatric Usage Safety and effectiveness in children, below the age of 12 years, have not been established. Adverse Reactions No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and physician notified immediately. To report SUSPECTED ADVERSE REACTIONS, contact Obagi Medical Products, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Contraindications People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established. How is Obagi-C Rx System Supplied Obagi-C Rx System C-Clarifying Serum (Hydroquinone, USP 4%) for Normal to Dry Skin is available as follows: 1 fl. oz. (30 mL) bottle NDC 62032-106-10 Obagi-C Rx System C-Clarifying Serum (Hydroquinone, USP 4%) for Normal to Oily Skin is available as follows: 1 fl. oz. (30 mL) bottle NDC 62032-122-10 Obagi-C Rx System C-Therapy Night Cream (Hydroquinone, USP 4%) is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-105-36 Store at controlled room temperature: 15 to 25 C (59 to 77 F). Keep out of direct sunlight. Distributed by: Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA U.S. Patent 6,299,889 Obagi-C is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. OMP, Inc. www.obagi.com 9578900 Revised: 10/2016 PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton OBAGI-C RX SYSTEM NDC# 62032-105-36 C-THERAPY NIGHT CREAM SKIN LIGHTENING CREAM WITH VITAMIN C & E HYDROQUINONE USP, 4% RX ONLY PM Net wt. 2 oz. (57 g) Obagi-C Rx System C-THERAPY SKIN LIGHTENING WITH VITAMINS C AND E hydroquinone cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62032-105 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID BUTYLATED HYDROXYTOLUENE CETYL ALCOHOL EDETATE DISODIUM GLYCERIN LACTIC ACID, UNSPECIFIED FORM METHYLPARABEN PHENYL TRIMETHICONE PPG-2 MYRISTYL ETHER PROPIONATE PROPYLPARABEN SODIUM LAURYL SULFATE SODIUM METABISULFITE TROLAMINE SALICYLATE .ALPHA.-TOCOPHEROL ACETATE WATER Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:62032-105-36 57 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2010 Labeler - OMP, INC. (790553353) Establishment Name Address ID/FEI Operations Ei LLC 105803274 MANUFACTURE(62032-105) Revised: 10/2016 OMP, INC. Next Pregnancy Warnings Print this page Add to My Med List More about Obagi-C Rx System C-Therapy Night Cream (hydroquinone topical) Side Effects During Pregnancy Dosage Information 0 Reviews Add your own review/rating Drug class: topical depigmenting agents Consumer resources Professional resources Obagi C Rx System C Therapy Night (FDA) Hydroquinone (AHFS Monograph) Other brands: Melamin , Lustra , Melquin HP , Melpaque HP , ... +18 more Related treatment guides Dermatological Disorders} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical depigmenting agents Related Drugs topical depigmenting agents hydroquinone topical , Melamin , Tri-Luma , Lustra Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , urea topical , Clobex , Valisone , Proctofoam HC , hydroquinone topical , sodium hyaluronate topical , Olux , Betamethacot , Diprosone , salicylic acid topical , Melamin , Diprolene AF , Celestone Soluspan , Analpram E , Clobevate , More... 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