OTCS

Interest of this reaction is that uses OTC chemicals or non suspicious, as NaN02 (it s used in food industry as a conserver), and it s really easy. Methanol used is drugstore methanol, PdCk is from photografy supplier in the net or elsewhere... 

Hexamine, more formally known as Hexamethylenetetramine, is easily and conveniently produced from Formaldehyde and Ammonia solutions. Formaldehyde may be easily produced by depolym-erizing, with heat, Paraformaldehyde (the only ingredient in OTC MildewCide). Hexamine is then reacted with Hydrochloric Acid and heated to yield Methylamine HCI in near quantitative yield. 

The market for antiulcer agents (Fig. 1) is large and is comprised of both prescription and over the counter (OTC) products. The estimated prescription market is over 3 biUion aimuaHy in the United States, whereas the more difficult to estimate OTC market is in the range of 500 million aimuaHy. Several pharmaceutical companies are attempting to obtain approval for OTC use of prescription-only agents, and patent protection for several of the histamine antagonists mns out in the mid-1990s. 

Phenolphthaleia is a cathartic dmg and the basis of many OTC laxatives. Its action is mainly on the colon to produce a soft semifluid stool within six to eight hours. Its action may persist for several days owiag to enterohepatic circulation and it may cause red urine if urine is alkaline. 

Loperamide is similar ia action and use to diphenoxylate however, it does not need to be formulated with atropiae and is available by prescription and OTC. It is reported to have fewer central nervous system side effects than diphenoxylate. 

Dimenhydrinate is an antiemetic especially usehil as an antinauseant in motion sickness, and for syndromes associated with vertigo such as Meniere s syndrome, radiation sickness, and vestibular dysfunction. It may produce mild drowsiness. It is FDA Category B for Pregnancy, and is available as an OTC preparation as well as by prescription. 

Dmg products must meet the requirements estabUshed by the Center for Dmg Evaluation and Research at FDA. They must comply with the appropriate OTC Dmg Review Fiaal Rule pubHshed ia the Federal Register or must be the subject of an approved New Dmg AppHcation (NDA) filed with FDA. Products not meeting these requirements are considered by FDA to be New Dmgs without an NDA and subject to regulatory action. 

FDA has pubHshed two final rules for hair products as of this writing (69). Any over-the-counter (OTC) dmg product labeled or promoted for external use as a hair grower or for hair loss prevention is regarded as a new dmg and must be the subject of an approved new dmg appHcation (NDA). Products making these claims without an NDA are considered to be ia violation of the Federal Food, Dmg and Cosmetic Act and are also mislabeled. 

The FDA has passed a rule (21 CFR 211.132) (3) requiring the use of tamper-evident packaging on all over-the-counter (OTC) dmgs and some cosmetics (qv), while ignoring other products they regulate (2). Table 1 offers examples of such packaging forms. 

The principal OTC pharmaceutical products include cold remedies, vitamins and mineral preparations, antacids, analgesics, topical antibiotics, antiftingals and antiseptics, and laxatives. Others include suntan products, ophthalmic solutions, hemorrhoidal products, sleep aids, and dermatological products for treatment of acne, dandmff, insect parasites, bums, dry skin, warts, and foot care products (11). More recent prescription-to-OTC switches have included hydrocortisone, antihistamine and decongestant products, antiftingal agents, and, as of 1995, several histamine H2-receptor antagonists. 

From 1981 to 1995 other dmgs switched to OTC were the antifiingal preparations containing micona2ole nitrate [22832-87-7] (7) and clotrima2ole [23593-75-1] (8) the antiinflammatory agent ibuprofen [15687-27-1] (9) and the histamine H2-receptor antagonists famotidine [76824-35-6] (10) and cimetidine [51481-61-9] (11). 

OTC Facts and Figures, Nonprescription Drug Manufacturers Association, Washington, D.C., 1995. 

Sahcyhc acid USP, EP, and other pharmacopeia grades are used medically as antiseptic, disinfectant, antifungal, and keratolytic agents. Sahcyhc acid is formulated in lotion or ointment formulations for the treatment of dandmff, eczema, psoriasis, and various parasitic skin diseases. Because the keratolytic property of this aromatic acid has use in the safe removal of dead skin cells from the surface of healthy skin, the acid is used in concentrated sahcyhc acid solutions or suspensions to remove warts and corns. In more dilute form, sahcyhc acid preparations have found use in dandmff and eczema treatment. Sahcyhc acid has been considered and found effective by the Advisory Committees to the FDA in various over-the-counter (OTC) dmg regulated uses. Among these are acne products, dermatitis, dry skin, dandmff and psoriasis products, and foot care products (24). 

Horn omen thyl saUcylate (homosalate), employed as a sunscreen agent, is on a Hst of 21 compounds for OTC sunscreen products, recommended by the FDA advisory review panel on OTC bum and sunburn prevention as both "safe and effective" (30). Menthyl saUcylate (6) is also a sunscreen agent. 

Uses. Aspirin has analgesic, antiinflammatory, and antipyretic activity. It is used for the reHef of less severe types of pain, such as headache, neuritis, acute and chronic rheumatoid arthritis, and toothache. Aspirin can be purchased in a variety of OTC and prescription dosage forms made and formulated by many companies. Tablets, ie, buffered, plain, or enteric-coated, are the most familiar in the United States, but other forms such as powder and effervescent formulations are of considerable importance in other parts of the world. 

L-Ascorbic acid is used as a micronutrient additive in pharmaceutical, food, feed, and beverage products, as weU as in cosmetic appHcations. The over-the-counter (OTC) vitamin market is strong, growing in demand, and vitamin C is available in the form of piUs and tablets to supplement the daily diet to maintain peak physical performance. 

As iadicated ia Table 1, phenylpropanolamiae [14838-15-4] is the one agent Hsted which is available over the counter (OTC). It is... 

Economic summaries of the cosmetic industry, commonly documented by sales volume, are sometimes based on unit sales, sometimes on manufacturers sales in monetary units, and sometimes on consumer spending. Figures normally include contributions by private labeling operations but do not necessarily reflect the value of the industry service sector, which includes suppHers of raw materials, beauticians, testing laboratories, and other speciaHsts. Moreover, product categories caimot be rigidly defined. For example, the differentiation between a deodorant (a cosmetic) and an antiperspirant (an OTC dmg) is often obscured by its trade name. 

In contrast to prescription dmgs, OTC dmgs and cosmetics are not subject to preclearance in the United States. However, the rules covering OTC dmgs preclude introduction of untested dmgs or new combinations. A "new chemical entity" that appears suitable for OTC dmg use requires work-up via the new dmg appHcation (NDA) process. In contrast, the use of ingredients in cosmetics is essentially unrestricted and may include less well known substances. 

The abihty of skin-care products to supply moisture to the skin remains in question. In the United States, however, the OTC panel has sanctioned the use of skin-protectant ingredients such as glycerin, which may play roles in the skin s water ecology. Products for the care of body skin are similar to preparations formulated for the care of facial skin. Products for overall body care should leave a dry, satinlike finish even though relatively high levels of... 

As of 1991 in the United States, OTC antiacne preparations may contain only a few active dmgs, for example, sulfur [7704-34-9] resorcinol acetate [102-29-4], resorcinol [108-46-3], salicylic acid [69-72-7], and some combinations (52). OTC anti-acne constituents maybe included in a variety of conventional cosmetic preparations, which then become OTC dmgs. These include lotions, creams, solutions, facial makeups, facial cleansers (including abrasive cleansers), and astringents. Products must contain the specified dmgs at the designated concentrations. Compositions of antiacne products have beenpubhshed (53). 

In vitro absorption-spectrophotometry techniques are available to assess a sunscreen s efficacy, but the preferred methods are in vivo procedures in which a small body site is irradiated with the desired wavelengths for different periods in the presence or absence of a uv protectant. Procedures vary from country to country to determine the incremental timing of the exposure that ultimately allows quantification via sun protective factor (SPE). In the United States, sunscreen preparations are considered OTC dmg products, and the SPE must be specified (54). Even in countries that do not identify these products as dmgs, SPE labeling has become customary. 

In the United States, some astringents, depending on product claims, are considered OTC dmgs (62). Only three ingredients, aluminum acetate [139-12-8], aluminum sulfate [10043-01-3], and hamameHs [84696-19-5], are considered safe and effective. 

States, derivatives in which some of the water and related derivatives can be used in OTC... 

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