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Makeup Myths and Facts
Myth: Cosmetics are not regulated.
Fact: and their individual ingredients must be safe, and labeling must
be truthful and not misleading. The U.S. Food and Drug Administration has legal
authority over cosmetics similar to its authority over other FDA-regulated
products, such as foods,nonprescription drugs and nonprescription medical
devices. For instance, the FDA can take immediate action to stop the sale of
any cosmetic product that does not meet its standards.
Myth: Cosmetics contain dangerous, toxic ingredients.
Fact: FDA regulations require that all ingredients used in cosmetics be
substantiated for safety. If this isn't done, the product's label must read:
"WARNING: The safety of this product has not been determined." In the
U.S., cosmetic manufacturers are required by law to establish the safety of
both finished products and their ingredients.
Myth: No independent body evaluates the safety of cosmetic
ingredients.
Fact: The cosmetic industry supports an independent panel of world-class
medical and scientific experts, the Cosmetic Ingredient Review Expert Panel
(CIR). This scientific body examines all available data and assesses the safety
of ingredients used in cosmetics. CIR publishes its findings in the
peer-reviewed International Journal of Toxicology and has restricted or banned
the use of hundreds of chemical ingredients owing to concerns over consumer
safety.
Myth: Cosmetic and personal care products often contain substances
known or suspected of causing cancer and reproductive toxicity.
Fact: No credible research has ever shown that any cosmetic or personal
care products cause cancer or reproductive toxicity. Chemicals found to be
human carcinogens are not used in cosmetics. In fact, very few reports of
injury involving cosmetics have ever been reported.
Myth: Cosmetic companies can use any ingredient they want in their
products.
Fact: By law, every cosmetic on the shelf must be safe. In the U.S.,
cosmetics are regulated under the Food, Drug and Cosmetic Act, which is
enforced by the FDA. The FDA has the legal authority to regulate the safety of
cosmetic products; however, it has comparatively little need to use its
authority, because cosmetics are composed of safe ingredients and because, when
necessary, the cosmetics industry has acted voluntarily to withdraw ingredients
that have been scientifically shown to have the potential for adverse
effects.
Myth: Skin-care products are all hype; soap and water works just as
well.
Fact: The science behind skin-care products has grown in leaps and
bounds over the past 20 years. Today, there is good scientific evidence behind
the use of such ingredients as antioxidant vitamins, green tea polyphenols,
retinoids, alpha- and beta-hydroxy acids and essential oils in skin-care
products to minimize wrinkles, fade dark spots and strengthen collagen.
WebMD Medical Reference
Skin & Beauty Guide
VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
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 Full Prescribing Information for Vivelle-Dot.
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