Microdermabrasion Device Firms Receive
FDA/CFSAN - Hair Removal and Microdermabrasion Device Firms Receive Warning Letter FDA Home Page | CFSAN Home | Search/Subject Index | Q & A | Help CFSAN/Office of Cosmetics and Colors Fact Sheet February 19, 2002; Revised November 16, 2004 Hair Removal and Microdermabrasion Device Firms Receive Warning Letters WarningLetters issued by FDA to the manufacturer of a hair removal system (available in HTML and PDF ) and the manufacturerof a microdermabrasion device (available in PDF ) illustrate an important legal distinction -- the difference between the legal definitions of cosmetics and medical devices. Although the devices cited in these Warning Letters are intended to affect a person's appearance,the fact that a product is used to diagnose or treat a medical condition or affect the structure orfunction of the body makes it a medical device, not a cosmetic, under the Federal Food, Drug, & Cosmetic Act (FD&C Act). The FD&C Act requires medical device manufacturers to obtain marketing clearance for their productsbefore offering them for sale [ FD&C Act, section501(f)(1) ]. The law does not require clearance or approval to market cosmetic products or ingredients.(An exception is color additives , which are covered separately in section 721 of the FD&C Act .) In addition,medical devices are subject to the Quality System Regulation (21 CFR part 820). Cosmetics are not subject to thisregulation. This is how the FD&C Act defines a device: The term ''device'' (except when used in paragraph (n) of thissection and in sections 301(i), 403(f), 502(c), and 602(c)) means aninstrument, apparatus, implement, machine, contrivance, implant, in vitroreagent, or other similar or related article, including any component, part,or accessory, which is - (1) recognized in the official National Formulary, orthe United States Pharmacopeia, or any supplement to them, (2) intended foruse in the diagnosis of disease or other conditions, or in the cure,mitigation, treatment, or prevention of disease, in man or other animals, or(3) intended to affect the structure or any function of the body of man orother animals, and which does not achieve its primary intended purposesthrough chemical action within or on the body of man or other animals andwhich is not dependent upon being metabolized for the achievement of itsprimary intended purposes. [FD&C Act, section 201 (h)] This is how the FD&C Act defines a cosmetic: The term ''cosmetic'' means (1) articles intended to be rubbed,poured, sprinkled, or sprayed on, introduced into, or otherwise applied to thehuman body or any part thereof for cleansing, beautifying, promotingattractiveness, or altering the appearance, and (2) articles intended for useas a component of any such articles; except that such term shall not includesoap. [FD&C Act, section 201(i)] For related information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) , Cosmeceuticals , Soap , Warning Letters , and Medical Devices . Warning Letter to Rejuvenu International Ltd. (available in HTML and PDF ). August 16, 2004 Warning Letter to Biorem s.r.l. (available in PDF ). December 14, 2001 Cosmetics CFSAN Home | CFSAN Search/Subject Index | CFSAN Disclaimers & Privacy Policy | CFSAN Accessibility/Help FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA FDA/Center for Food Safety & Applied Nutrition Hypertext updated by bxm/cjm/dav November 16, 2004 skin treatment options. OurPenn Plastic Surgery: Skin Care Program Appointments | Medical Services | Health Information | Find a Doctor Search: Overview | Cosmetic Surgery | Reconstructive Surgery | Skin Care Program Overview Procedures Skin Care Program Overview Services Why choose Penn? For more than 10 years, aestheticians of the Skin Care Program have offered non-surgical techniques, treatments and products to rejuvenate the skin. They present the latest anti-aging therapies, as well as skin care options for those with acne, rosacea and sensitive skin. The program's clinical services are also excellent for those who have had or plan to invest in cosmetic surgery. Patients with healthy skin before surgery recover more quickly and have healthier skin after their procedure. Services During your first consultation with an aesthetician, or skin care professional, be prepared to discuss the concerns you have about your skin. The aesthetician will listen, examine your skin to determine your skin type, ask about medicines you may be taking that effect your skin and talk with you about the best options for skin rejuvenation. The Skin Care Program offers a wide range of services, including: Camouflage make-up Chemical peels Intense pulsed light (IPL) Laser hair removal Microdermabrasion Micropigmentation Why choose Penn? Whether you are interested in a specific procedure or just want help looking your very best, the Skin Care Program offers a relaxed and caring environment. Patients see one of four state-licensed aestheticians trained in clinical skin treatment options. Our caring team will be attentive to your needs and concerns as they help you learn a new approach to skin care. Our aestheticians are among the area’s best: Betsy Rubenstone, Certified Medical Aesthetician; Medical Assistant; past-president, Society of Plastic Surgical Skin Care Specialists JoEllen Cozen, Certified Medical Aesthetician Amanda Gross, Certified Medical Aesthetician Jeanne Vos, Certified Medical Aesthetician The Skin Care Program carries only physician-recommended skin products that we believe to be effective, including: La Roche-Posay BioMedic Perricone Cosmeceuticals SkinCeuticals SkinMedica For more information or to make an appointment, please call 1-800-789-PENN (7366) and ask for the Plastic Surgery Skin Care Program. Need an appointment? Request one online 24 hours a day, 7 days a week; or call 1-800-789-PENN (7366) to speak to a referral counselor. Related Links Find a Plastic Surgeon Request an Appointment Online or call 1-800-789-PENN (7366) Visitor Information Encyclopedia Articles about Plastic Surgery About UPHS Contact Us Site Map Privacy Statement Legal Disclaimer Terms of Use The University of Pennsylvania Health System, Philadelphia, PA © 2006, The Trustees of the University of Pennsylvania Skin Cream - 4Mother's Friend - Skin Cream - 4 oz Shop In Private Skin Care Mother's Friend - Skin Cream - 4 oz Mother's Friend - Skin Cream - 4 oz Mothers Friend Body Skin Cream Mother's FriendBody Skin Cream Mothers Friend creamhelps soothe and condition stretched, dry skin during pregnancy.After pregnancy Mothers Friend ma kesan excellent skin conditioner anytime. Use it often to help keepskin beautifully soft and supple. Even works on rough on roughheels, knees and elbows. One jar, net weight4 oz. (113g) Ingredients: Purified water, Isopropyl Myristate, Lanolin, Propylene Glycol, Cetyl Alcohol, Glyceryl Monostearate, Silicone, Stearic Acid, Tromethamine, Preservative, TEA-Lauryl Sulfate, Fragrance Allantoin, FDC Red 40, and DC Red 28 This is a very popular item here at ShopInPrivate.com. Mother's Friend receives unanimously good reviews. FN143-4695 $5.49 shipping weight = (7.8) oz. Click here for more info about our fair shipping prices. Don't forget to check out these other versatile items: Balmex Diaper Rash Cream - 16 oz. SF133-0703 $12.49 Benson's Bottom Paint - Diaper Rash Ointment SF120-5467 $10.99 Folic Acid Tablets 400 mcg each - 240 tablets D172-4301 $4.19 Johnson and Johnson Baby Oil - 20 oz. SF172-3501 $4.59 Johnson's head-to-toe Baby Wash H119-2251 $3.99 Johnsons Baby Oil - Creamy Formula - 15 oz. SF216-5744 $3.69 Nursing Support Tablets - 120 FN218-5270 $13.99 Pin-X - Pinworm treatment - 1 oz. AO349-2634 Was: $12.99 New Price: $10.99, 6 for $59.94 Poison Emergency Kit G272-4730 $9.99 Stretch Mark Cream - by Vita K SF117-1578 $11.99 embarrassing products , hardto find items , feminineneeds , men'shealth , birthcontrol , ailmentproducts , incontinence , diet products , personal hygiene , hair , skin care , home tests , gifts , ShopInPrivate Site Index, by Isdera Corp., Hazel Park, Michigan Click here to tell a friend about ShopInPrivate.com. Spa SaltFinnish Touch Day Spa - Beauty & Fitness - Salt Lake City, UT, 84108 - Citysearch BOC Spa & Beauty: Vote for your fave today -- New to Citysearch? Sign In · Help · Jan 26 2006 Home Restaurants & Bars Hotels Shopping Spa & Beauty Movies Events See More Categories » Search Business name, category, and/or keyword Search by name only Address, city & state, or zip Address, city & state, or zip | Neighborhood Address, city & state, or zip | Airport Address, city & state, or zip | Attraction Select a Utah Neighborhood Select an Utah Airport Select an Utah Attraction My Locations Add/edit locations Recent Locations Clear recent locations Save to My Citysearch Printer Friendly Version Home · Yellow Pages · Beauty & Fitness · Spas · Profile Spa and Beauty: Best Facials 2006 Thank you for your vote. Please check out other categories . Photo by Simon Blundell Finnish Touch Day Spa 1301 S 2100 E Salt Lake City, UT 84108 (801) 582-3467 (801) 582-4700 (Fax) Editorial Profile Bundle up in a fluffy white robe and slippers and stroll through for a day of... Read More | User Reviews (16) 9.2 Overall Recommended About our ratings Ratings feedback Send to a Friend Business Info Hours: · Mon 9am-6pm · Tue-Fri 9am-7pm · Sat 9am-6pm Payment: · ATM · American Express · Cash · Gift Certificate · MasterCard · Visa Parking: · Lot Own this business? » Enhance or edit your listing See something wrong? » Suggest a correction Things to do nearby: 1301 S 2100 E Salt Lake City, UT 84108 · Restaurants · Hotels · Bars · Movie Theaters · Department Stores · Shopping Centers & Malls · Grocery Stores · Pharmacies · Florists · Banks Related Searches · Salt Lake City Beauty & Fitness · Search anything in Utah · Search Yellow Pages in Utah · Search other Cities · Browse Utah Editorial Lists Finnish Touch Day Spa A message from this business Affordable escape close to Downtown. Let us treat you to a soothing day View more A peaceful European day spa. Finnish trained, paramedical esthetician, Sinikka Brady, with over 25 years experience, has created a truly therapeutic and healing environment for your mind, body, and spirit.Personalized skin care Spa body treatments include Authentic Finnish Sauna Hair and make-up artistry Gift certificates available Employee incentive package Close Citysearch Editorial Profile -- By Robyn Galbos Bundle up in a fluffy white robe and slippers and stroll through for a day of pure pampering. Editorial Rating: Not Rated The Scene Sleek, modern and definitely comfortable, Finnish Touch is a world-class day spa where beautiful people tend to your every need. For those who enjoy a little self-indulgence at home, there are plenty of products for hair, nails, face and body. The Services This is the perfect pre-wedding destination. Exfoliate with a salt-glow treatment to leave your skin feeling baby soft or relax with a massage, then create a polished appearance with a manicure and pedicure. Salon services also are available--complete your look by having your hair and makeup done. Other treatments include sea-mud wraps, body contour wraps and personalized facials. Body-bronzing treatments with self-tanning lotion give clients a tan without the damaging rays of the sun and avoid the telltale blotches you get when you apply the stuff yourself. Spa packages are available. Head-to-toe pampering includes a massage, facial, manicure and pedicure. Editorial content is independent of paid advertisers. Any expenses are paid for by Citysearch. Insider Tips Parking There's a small free lot just south of the building reserved for spa patrons. The Extras The spa carries many hard-to-find products, like the Fresh line, Peter Thomas Roth and Murad. Know Before You Go Gift certificates and baskets are available--great for anniversaries, Valentine's Day or birthdays. User Reviews What users are saying Satisfaction: yes Sanitary: yes Sales Pressure: no On time: yes Evening hours: yes Write a review and share your thoughts with other users. Always good, without pretention or too much fluff Posted by ladylu on 01/05/2006 This is undoubtedly the best spa in the state, if not absolutely one of the best in the country. I've been going there for years, and have tried out several others that spring up around the city. They're all nice; they don't seem to have the essense the Finnish Touch brings time and time again. My skin always feels rejuvenated and it definitely glows as promised. I Get the microdermabrasion once a month. I'll always go back Pros: good price, friendly staff, great products Overall user rating: Highly Recommended Was this review helpful: Yes or No | Request removal of this review » Read all 16 reviews Related Editorial Content Day Spas Need some pampering? Indulge in a relaxing massage, manicure, facial or body treatment at a top Utah day spa. Local Wedding Resources Your guide to Utah's wedding resources, from florists and dress shops to ceremony and reception sites. Relaxing in Utah: Insider's Guide Insider tips on some of Salt Lake City's top spas and salons. View More » Specialty ratings for Finnish Touch Day Spa: 9.9 Facials Vote 8.6 Hair Salon Vote 9.6 Manicures & Pedicures Vote View All 9.9 Massage Vote 9.8 Spa Vote Close Utah What's the best in your city? Choose a category: View All Categories Facials Hair Salon Health Club Manicures Massage Spa Yoga Recognition for Finnish Touch Day Spa 2002 2002 Editorial Winner Best Spa 2002 National Winner Best Spa Nominated for Best Spa About Us | Advertise with Us | Contact Us | Press Center | Site Guide | List Your Business on Citysearch | Become an Affiliate | Job Opportunities | Other Cities | Get a Business Website | Submit an Event | Privacy Policy | Terms of Use | About BOC | Utah Yellow Pages Citysearch is a registered trademark of 720619 Ontario Inc. and is used under license (C) 2006 Citysearch.com All rights reserved. partner sites: Evite - Entertainment.com - Gifts.com - TripAdvisor - ServiceMagic - Ticketmaster - Expedia - Hotels.com - Hotwire - HSN - LendingTree - Match.com - RealEstate.com - ReserveAmerica - Zerodegrees - CondoSaver - ClassicVacations - Ballard Designs - Frontgate - Garnet Hill - Smith+Noble - The Territory Ahead - Travel Smith Sensitive Skin Overall rating:Compare Prices and Read Reviews on Dove Roll-On, Antiperspirant & Deodorant, Sensitive Skin at Epinions.com Join Epinions | Help | Sign In Fragrances Beauty All Categories Advanced Search Home > Gifts > Fragrances Dove Roll-On, Antiperspirant & Deodorant, Sensitive Skin Overall rating: Reviewed by 3 Epinions users Write a Review Compare Prices View Details Read Reviews Subscribe to reviews on this product Read Review of Dove Roll-On, Antiperspirant & Deodorant, Sensitiv... Review Summary About the Author Sensitive Skin?Try Dove Roll-On Antiperspirant & Deodorant May 13 '05 Author's Product Rating Pros Did not break my daughters skin out Cons I bought the wrong version the first time, bottles look to similar. The Bottom Line I highly recommend this product. It seemed very gentle on my daughters skin, yet still worked effectively. Full Review I had heard about Dove Roll-On Antiperspirant & Deodorant, for Sensitive Skin, by my daughters pediatrician. My daughter suffers from all sorts of skin allergies. Her doctor also has skin allergies, and she swears by this product. At first I had went to purchase this product, and accidentally bought it in the powdered version. Next trip to the store, I purchased the Sensitive Skin, unscented version. I kept the powdered scent bottle for myself. Pricing, and Description of Product I purchase all of my beauty, and skin care items at CVS Pharmacy. Its a bit more expensive, but since I am always running back and forth to the pharmacy, I find it more convenient for me. I purchased the Dove 2.5 fl. oz plastic bottle, for around $2.99. I probably could have found this product a bit cheaper at Walmart. Dove Roll-On, Antiperspirant & Deodorant, Sensitive Skin features a plain white plastic bottle, with a light blue twist lid. What I like about this deodorant is that the plastic ball in this deodorant, measures close to 2 inches. I prefer the larger roll-on tops over the small. This product was easy to remove, and I had experienced no problems with dripping. When purchasing this product, be sure you read the label. The powdered version and the sensitive version, come in just about the same looking bottles. The powdered scent however has the word Powder printed very small in pink. Where as the Sensitive is in blue. How Did Dove Measure Up? My daughter really liked her Sensitive Skin version. She claimed that she had all day coverage, and did not experience any breakouts or redness. She too also liked the idea of a bigger roll-on. My daughter is on the soccer team, and she really needs something that will give her long lasting coverage, with out burning her. My daughter was using a stronger deodorant prior to Dove. She found that when she sweats, the combination of sweating, and the perfume in her deodorant was making her break out. I enjoyed my Powdered version. The only complaint I had, in which my daughter agrees with her sensitive version, is that once you apply this product to the underarms, it feels a bit sticky until it completely dries. It did not take long for either version to dry, and the sticky feeling soon went away. Both of us would purchase Dove Roll-On, Antiperspirant & Deodorant products again. It was very quick, convenient, and long lasting. Ingredients and Product Claims Ingredients found on bottles: "The active Ingredient in both of these products are Aluminum Chlorohydrate." " Dove claims that this product will, "Reduce underarm wetness, as well as give 24 hour protection." Warnings Your basic "don't consume, and if you experience a rash, discontinue, Keep away from children, and apply to underarms only." I did find one strange warning in particular, it says to: "Consult your doctor if you have Kidney Disease." I have never heard of such warning before. Once I started looking on my other deodorant bottles, I noticed the same warning. This leaves me wondering how this product is linked to the kidneys? Directions: "Shake this product well with the cap on, and apply to underarms only." "Questions or Comments: 1-800-761-Dove" Overall? Skin allergies can be a terrible thing. If you can find a product that does not break you out, it really makes a world of difference. Thanks Dove, my daughter and I both love these products! Recommended Yes Comments on this Review Read all comments (4) Write your own comment Epinions.com ID: LILvoyce in Home & Garden in Home & Garden Member: Barbara Location: FLORIDA Reviews written: 335 Trusted by: 483 members ~~ Cleaning Product Fanatic~~ View all reviews by LILvoyce View LILvoyce's profile Return to top Back to all reviews Featured Resources Additional information on Dove Roll-On, Antiperspirant & Deodorant, Sensitive Skin or other products. Dove Sensitive Skin Buy Health Products at Amazon.com Huge Selection at Great Low Prices Amazon.com/health Buy it at drugstore.com Free shipping and get 5% back Great Selection - Easy Returns www.drugstore.com Buy Dove Deodorant We sell All Dove Deodorant Save Time and Money Bargain Prices! www.NationwideCampus.com Tabu Roll-On Deodorant Stay refreshed with your favorite scent! $0.89 www.amerimark.com Jason Beauty Has It Wholesale discounts on entire line of Jason Natural Beauty Products www.JasonBeauty.com Help | Member Center | Message Boards | Site Rules | User Agreement | Privacy Policy | Site Index About Epinions | Careers | Contact Epinions | Advertising Epinions | DealTime USA | DealTime UK | PriceTool | Shopping.com | Rent.com © 1999-2006 Epinions, Inc. Trademark Notice Epinions.com periodically updates pricing and product information from third-party sources, so some information may be slightly out-of-date. You should confirm all information before relying on it. |
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