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Over-the-counter Drug
OVER-THE-COUNTER (OTC) DRUGS are medicines sold directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs , which may only be sold to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician 's care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. The term over-the-counter may be somewhat counterintuitive , since, in many countries, these drugs are often placed on shelves in self-service areas of stores, like any other packaged products. In contrast, prescription drugs are almost always passed over a counter from the pharmacist to the customer
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Combat Methamphetamine Epidemic Act Of 2005
The COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005 (CMEA) is federal legislation enacted in the United States on March 9, 2006, to regulate, among other things, retail over-the-counter sales of following products because of their use in the manufacture of illegal drugs: * ephedrine * pseudoephedrine * phenylpropanolamine (no longer OTC due to a proposed increased risk of stroke in younger women)Retail provisions of the CMEA include daily sales limits and 30-day purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, employee training, and self-certification of regulated sellers. The CMEA is found as Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (H.R. 3199). The last provisions of the law took effect on 30 September 2006
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Active Ingredient
An ACTIVE INGREDIENT (AI) is the ingredient in a pharmaceutical drug that is biologically active . The similar terms ACTIVE PHARMACEUTICAL INGREDIENT (API) and BULK ACTIVE are also used in medicine, and the term ACTIVE SUBSTANCE may be used for natural products. Some medication products may contain more than one active ingredient. The traditional word for the API is PHARMACON or PHARMAKON (from Greek : φάρμακον, adapted from pharmacos ) which originally denoted a magical substance or drug. The term ACTIVE CONSTITUENT is often chosen when referring to the active substance of interest in a plant (such as salicylic acid in willow bark or arecoline in areca nuts ), because the word ingredient in many minds connotes a sense of human agency (that is, something that a person combines with other substances), whereas the natural products present in plants were not added by any human agency but rather occurred naturally ("a plant doesn't have ingredients")
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Over-the-counter (finance)
OVER-THE-COUNTER (OTC) or OFF-EXCHANGE trading is done directly between two parties, without the supervision of an exchange . It is contrasted with exchange trading , which occurs via exchanges . A stock exchange has the benefit of facilitating liquidity , mitigates all credit risk concerning the default of one party in the transaction, provides transparency , and maintains the current market price . In an OTC trade, the price is not necessarily published for the public. OTC trading, as well as exchange trading, occurs with commodities , financial instruments (including stocks ), and derivatives of such products. Products traded on the exchange must be well standardized. This means that exchanged deliverables match a narrow range of quantity, quality, and identity which is defined by the exchange and identical to all transactions of that product. This is necessary for there to be transparency in trading. The OTC market does not have this limitation
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Cinnarizine
CINNARIZINE is a medication derivative of piperazine , and characterized as an antihistamine and a calcium channel blocker , it is also known to promote cerebral blood flow, and so is used to treat cerebral apoplexy , post-trauma cerebral symptoms, and cerebral arteriosclerosis. However, it is more commonly prescribed for nausea and vomiting due to motion sickness or other sources such as chemotherapy , vertigo , or Ménière\'s disease . Cinnarizine
Cinnarizine
was first synthesized by Janssen Pharmaceutica in 1955. The nonproprietary name is derived from the cinnamyl substituent on one of the nitrogen atoms, combined with the generic ending "-rizine" for "antihistaminics/cerebral (or peripheral) vasodilators". It is not available in the United States or Canada. It has also been cited as one of the most used drugs for seasickness within the British Royal Navy
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Diclofenac
DICLOFENAC (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and as an analgesic reducing pain in certain conditions. It is supplied as or contained in medications under a variety of trade names. The name "diclofenac" derives from its chemical name: 2-(2,6-DIChLOranilino) PHENylACetic acid. Diclofenac
Diclofenac
was first synthesized by Alfred Sallmann and Rudolf Pfister and introduced as VOLTAREN by Ciba-Geigy (now Novartis
Novartis
) in 1973. In the United Kingdom, United States, India, and Brazil diclofenac may be supplied as either the sodium or potassium salt ; in China, it is most often supplied as the sodium salt, while in some other countries it is only available as the potassium salt. It is available as a generic drug in a number of formulations, including diclofenac diethylamine , which is applied topically
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Inactive Ingredients
An EXCIPIENT is a substance formulated alongside the active ingredient of a medication , included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility. Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerned such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form , as well as the active ingredient and other factors
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Indication (medicine)
In medicine , an INDICATION is a valid reason to use a certain test, medication, procedure, or surgery. The opposite of an indication is a contraindication , a reason to withhold a certain medical treatment because it could harm a patient. DRUGSMost countries and jurisdictions have a licensing body whose duty is to determine whether to approve a drug for a specific indication, based on the relative safety of the drug and its efficacy for the particular use. In the United States, indications for medications are regulated by the Food and Drug Administration (FDA), and are included in the package insert under the phrase "Indications and Usage". The European Medicines Agency
European Medicines Agency
(EMA ) holds this responsibility for centrally authorized drugs in the European Union
European Union
. There are different classes of indication of drugs depending on validity of the benefit gained by the use of specific drug
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United States
Coordinates : 40°N 100°W / 40°N 100°W / 40; -100 United States
United States
of America Flag Great Seal MOTTO: " In God We Trust " Other traditional mottos * " E pluribus unum
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Mississippi
MISSISSIPPI (/ˌmɪsɪˈsɪpi/ ( listen )) is a state in the Southern United States
Southern United States
, with part of its southern border formed by the Gulf of Mexico
Gulf of Mexico
. Its western border is formed by the Mississippi River . The state has a population of approximately 3 million. It is the 32nd most extensive and the 32nd most populous of the 50 United States
United States
. Located in the center of the state, Jackson is the state capital and largest city, with a population of approximately 175,000 people. The state is heavily forested outside of the Mississippi Delta
Mississippi Delta
area, between the Mississippi
Mississippi
and Yazoo rivers. Before the American Civil War , most development in the state was along riverfronts, where slaves worked on cotton plantations. After the war, the bottomlands to the interior were cleared, mostly by freedmen
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Eczema
DERMATITIS, also known as ECZEMA, is a group of diseases that results in inflammation of the skin . These diseases are characterized by itchiness , red skin , and a rash. In cases of short duration there may be small blisters while in long-term cases the skin may become thickened . The area of skin involved can vary from small to the entire body. Dermatitis
Dermatitis
is a group of skin conditions that includes atopic dermatitis , allergic contact dermatitis , irritant contact dermatitis , and stasis dermatitis . The exact cause of dermatitis is often unclear. Cases are believed to often involve a combination of irritation, allergy , and poor venous return . The type of dermatitis is generally determined by the person's history and the location of the rash. For example, irritant dermatitis often occurs on the hands of people who frequently get them wet
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Dandruff
DANDRUFF is a skin condition that affects mainly the scalp . Symptoms include flaking and sometimes mild itchiness. It can result in social or self-esteem problems. A more severe form of the condition, which includes inflammation of the skin, is known as seborrheic dermatitis . The cause is unclear but believed to involve a number of genetic and environmental factors. The condition may worsen in the winter. It is not due to poor hygiene . The underlying mechanism involves the over growth of skin cells . Diagnosis is based on symptoms. There is no known cure. The typical treatment is with antifungal cream such as ketoconazole . Dandruff
Dandruff
affects about half of adults. Onset is usually at puberty . Males are more often affected than females. Rates decrease after the age of 50
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Psoriasis
PSORIASIS is a long-lasting autoimmune disease which is characterized by patches of abnormal skin. These skin patches are typically red , itchy, and scaly. They may vary in severity from small and localized to complete body coverage. Injury to the skin can trigger psoriatic skin changes at that spot, which is known as the Koebner phenomenon . There are five main types of psoriasis: plaque, guttate , inverse , pustular, and erythrodermic . Plaque psoriasis, also known as psoriasis vulgaris, makes up about 90% of cases. It typically presents with red patches with white scales on top. Areas of the body most commonly affected are the back of the forearms, shins, around the navel, and the scalp. Guttate psoriasis has drop-shaped lesions. Pustular psoriasis
Pustular psoriasis
presents with small non-infectious pus -filled blisters. Inverse psoriasis forms red patches in skin folds
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Federal Food, Drug, And Cosmetic Act
The United States FEDERAL FOOD, DRUG, AND COSMETIC ACT (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration
Food and Drug Administration
(FDA) to oversee the safety of food , drugs, and cosmetics. A principal author of this law was Royal S. Copeland , a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations
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Federal Trade Commission
The FEDERAL TRADE COMMISSION (FTC) is an independent agency of the United States
United States
government , established in 1914 by the Federal Trade Commission Act . Its principal mission is the promotion of consumer protection and the elimination and prevention of anticompetitive business practices, such as coercive monopoly . The Federal Trade Commission Act was one of President Woodrow Wilson 's major acts against trusts . Trusts and trust-busting were significant political concerns during the Progressive Era . Since its inception, the FTC has enforced the provisions of the Clayton Act , a key antitrust statute, as well as the provisions of the FTC Act , 15 U.S.C. § 41 et seq. Over time, the FTC has been delegated with the enforcement of additional business regulation statutes and has promulgated a number of regulations (codified in Title 16 of the Code of Federal Regulations )
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Code Of Federal Regulations
The CODE OF FEDERAL REGULATIONS (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law ) published in the Federal Register by the executive departments and agencies of the federal government of the United States . The CFR is divided into 50 titles that represent broad areas subject to federal regulation. The CFR annual edition is the codification of the general and permanent rules published by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office. In addition to this annual edition, the CFR is published in an unofficial format online on the Electronic CFR website, which is updated daily
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