Medesthetics

SEP 2018

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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Obagi Nu-Derm ® System plus 0.025% tretinoin*—corrects hyperpigmentation for a range of skin types 1,† Photos have not been retouched. Results may vary. Baseline Week 4 Baseline Week 24 *Tretinoin cream is indicated for topical application in the treatment of acne vulgaris, and is sold separately . † Study results for a 24-week evaluation of the effi cacy and tolerability of twice-daily use of the Obagi Nu-Derm Normal to Oily System plus 0.025% tretinoin; N=20. The safety of this system has not been evaluated beyond 24 weeks. If there is no improvement after 12 weeks, please discontinue use of the system. Please see Important Safety Information on the right. All products/brand names, whether designated by notice or not (®/™), are trademarks of Obagi Cosmeceuticals LLC. Distributed by Obagi Cosmeceuticals LLC. ©2018 Obagi Cosmeceuticals LLC. All rights reserved. NUD.0007.USA.18.r0 Important Safety Information for the Obagi Nu-Derm System (contains 4% hydroquinone) 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. WARNINGS: Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes, nose, mouth, or lips with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfi te, a sulfi te 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 sulfi te sensitivity in the general population is unknown and probably low. Sulfi te sensitivity is seen more frequently in asthmatic than in nonasthmatic people. PRECAUTIONS (ALSO 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 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. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted. See accompanying full Prescribing Information. INDICATION Tretinoin Gel 0.05% and Tretinoin Cream (0.1%, 0.05% and 0.025%) are used in the topical treatment of acne vulgaris. Tretinoin is for use on the skin only. Do not get it in your mouth, eyes, vagina or the corners of your nose. IMPORTANT SAFETY INFORMATION While using tretinoin, you should: • minimize exposure to the sun and to extreme cold or wind. Avoid sunlamps, tanning beds and ultraviolet light. • use a sunscreen with a SPF of at least 15, wear protective clothing and wide-brimmed hat • stop using tretinoin if you get a sunburn • avoid washing your skin too often, scrubbing the affected skin, or using other products with a drying effect, including other products containing tretinoin, unless recommended by your healthcare provider Before using tretinoin, tell your healthcare provider if you: • are allergic to fi sh (gel only). Contact your healthcare provider if you develop itching or rash while using tretinoin gel. • have a skin condition called eczema • have a sunburn • are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant or to breastfeed What are the possible side e ects of tretinoin? • skin dryness, burning, redness, excessive fl aking or peeling. If you develop these symptoms your healthcare provider may tell you to stop using it for a while, decrease the number of applications, or stop using it completely. Tell your healthcare provider about any side effect that bothers you or does not go away. The safety and effi cacy of Tretinoin have not been established in the treatment of patients younger than 10 years of age (Gel) or 12 years of age (Cream), or in pregnant or nursing women. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA- 1088. Please see accompanying Prescribing Information, including Patient Information.

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