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Ph. Eur. 5.5 (Water, Purified; Aqua Purificata). It is water for the preparation of medicines other than those that are required to be both sterile and apyrogenic, unless otherwise justified and authorised. It is prepared from suitable potable water either by distillation, by ion exchange, by reverse osmosis, or by any other suitable method. Store in conditions designed to prevent growth of micro-organisms and to avoid any other contamination. Sub-monographs cover Purified Water in Bulk and Purified Water in Containers.
Ph. Eur. 5.5 (Water, Highly Purified; Aqua Valde Purificata). It is water intended for the preparation of medicinal products where water of high biological quality is needed, except where Water for Injections is required.
USP 29 (Purified Water). It is prepared from potable water by a suitable process
Water for Injections
Ph. Eur. 5.5 (Water for Injections). It is water for the preparation of medicines for parenteral administration when water is used as the vehicle, and for dissolving or diluting substances or preparations for parenteral administration. It is prepared by distillation of potable water or purified water from a neutral glass, quartz, or suitable metal still fitted with an effective device for preventing the entrainment of droplets; the first portion of the distillate is discarded and the remainder collected. Store in conditions designed to prevent growth of micro-organisms and to avoid any other contamination. Sub-monographs cover Water for Injections in Bulk and Sterilised Water for Injections.
USP 29 (Water for Injection). It is purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and micro-organisms. When used for the preparation of parenteral solutions it should be sterilised first or the final preparation should be sterilised after preparation. Sterile Water for Injection, Inhalation, or Irrigation and Bacteriostatic Water for Injection are the
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Date of monograph revision: 02-Oct-1996; 05-Mar-1998; 10-Aug-2000; 17-Oct-2001; 10-May-2004; 08-Mar-2006; 20-Jul-2006
Synonyms: Gengibre; Gingembre; Gyömbér gyökértörzs; Imbierų šakniastiebiai; Ingefära; Ingwer; Inkivääri; Jengibre; Zázvorový oddenek; Zingib.; Zingiber; Zingiberis Rhizoma
In Chin., Eur. (see ), Jpn, and US.
Ph. Eur. 5.5 (Ginger). The dried, whole or cut rhizome of Zingiber officinale, with the cork removed, either completely or from the wide flat surfaces only. Whole or cut, it contains not less than 1.5% of essential oil, calculated with reference to the anhydrous drug. It has a characteristic aromatic odour. Protect from light.
The BP 2005 states that ginger may be known in commerce as unbleached ginger.
USP 29 (Ginger). The scraped or unscraped rhizome of Zingiber officinale (Zingiberaceae), known in commerce as unbleached ginger. It contains not less than 4.5% of alcohol-soluble extractive and not less than 10% of water-soluble extractive. Protect from light and moisture.
Ginger has carminative properties. It is used as a flavouring agent and has been tried for the prophylaxis of motion sickness and nausea and vomiting in pregnancy, although it does not seem to be effective for postoperative nausea and vomiting ().
It is also used in homoeopathic medicine.
Ginger oil is used in aromathe
The characteristic odor and flavor of ginger root is caused by a mixture of zingerone, shogaols and gingerols, volatile oils that compose about one to three percent of the weight of fresh ginger. In laboratory animals, the gingerols increase the motility of the gastrointestinal tract and have analgesic, sedative, antipyretic and antibacterial properties. In mice, ginger oil has been shown to prevent skin cancer and a study at the University of Michigan demonstrated that gingerols can kill ovarian cancer cells.
Ginger contains up to three percent of a fragrant essential oil whose main constituents are sesquiterpenoids, with (-)-zingiberene as the main component. Smaller amounts of other sesquiterpenoids (β-sesquiphellandrene, bisabolene and farnesene) and a small monoterpenoid fraction (β-phelladrene, cineol, and citral) have also been identified.
The pungent taste of ginger is due to nonvolatile phenylpropanoid-derived compounds, particularly gingerols and shogaols, which form from gingerols when ginger is dried or cooked. Zingerone is also produced from gingerols during this process; this compound is less pungent and has a spicy-sweet aroma. Ginger is also a minor chemical irritant, and because of this was used as a horse suppository by pre-World War I mounted regiments for feaguing.
Ginger has a sialagogue action, stimulating the production of saliva, which makes swallowing easier.
Extractum Zingiberis Fluidum (U. S. P.)—Fluid Extract of Ginger
Related entry:Zingiber (U. S. P.)—Ginger - Extracts and Fluid Extracts
Preparation.—"Ginger, in No. 40 powder, one thousand grammes (1000 Gm.) [2 lbs. av., 3 ozs., 120 grs.]; alcohol, a sufficient quantity to make one thousand cubic centimeters (1000 Cc.) [33 fl, 391]. Moisten the powder with two hundred and fifty cubic centimeters (250 Cc.) [8 fl, 218] of alcohol, and pack it firmly in a cylindrical percolator; then add enough alcohol to saturate the powder and leave a stratum above it. When the liquid begins to drop from the percolator, close the lower orifice, and, having closely covered the percolator, macerate for 48 hours. Then allow the percolation to proceed, gradually adding alcohol until the ginger is exhausted. Reserve the first nine hundred cubic centimeters (900 Cc.) [30 fl, 208] of the percolate, and evaporate the remainder, at a temperature not exceeding 50° C. (122° F.), to a soft extract; dissolve this in the reserved portion, and add enough alcohol to make the fluid extract measure one thousand cubic centimeters (1000 Cc.) 33 fl, 391]"—(U. S. P.).
Description, Medical Uses, and Dosage.—(See Zingiber). This is a transparent, brownish-red fluid, exhibiting strongly the sensible properties of ginger. Its strength is five-fold that of the tincture. Dose, from 1 to 20 minims.
Tinctura Zingiberis. U. S., Br.
Tincture of Ginger. Tr. Zingib. [Tincture of Jamaica Ginger]
Related entries: Tinctures - Ginger
Teinture (alcoole) de Gingembre, Fr. Cod.; Tinctura Zingiberis, P. G.; Ingwertinktur, G.
"Jamaica Ginger, in No. 30 powder, two hundred grammes [or 7 ounces av., 24 grains], to make one thousand mils [or 33 fluidounces, 6 1/2 fluidrachms]. Prepare a Tincture by Type Process P, using alcohol as the menstruum. Evaporate 10 Gm. of Tincture of Ginger to dryness in a tared dish on a water bath; the yield of residue does not exceed 2 per cent. When treated with 20 mils of cold distilled water, not more than 15 per cent. of this residue dissolves. Evaporate 10 mils of Tincture of Ginger to dryness in a small flask. Add 5 mils of half-normal alcoholic potassium hydroxide V.S. and boil the mixture gently for thirty minutes under a reflux condenser. Remove the condenser and evaporate the alcohol on a water bath. Then add 50 mils of distilled water to the residue, agitate the mixture, filter it and transfer the aqueous filtrate to a separatory funnel and shake it out with 25 mils of ether. Evaporate the separated ether solution spontaneously by adding it, a few drops at a time, to the center of a watch glass. Cautiously apply the tip of the tongue to the dry residue; the taste should be slightly camphoraceous but not sharp or bitingly-pungent (capsicum or similar pungent substitute). It contains about 90 per cent. of C2H5.OH by volume." U. S.
"Ginger, in No. 40 powder, 100 grammes; Alcohol (90 per cent.), sufficient to produce 1000 millilitres. Moisten the powder with one hundred millilitres of the Alcohol, and complete the percolation process." Br.
The strength of this tincture was reduced at the 1880 revision one-third, to bring it into the 20 per cent. class; this is not a disadvantage, however, in view of the introduction of the fluidextract, and the dose is not now inconveniently large.
The tincture of the British Pharmacopoeia is still too weak in the proportion of ginger. In consequence of the mucilaginous matter contained in ginger, the tincture made with diluted alcohol or proof spirit is apt to be turbid, and the drug is incompletely exhausted of its resinous and oily constituents. Alcohol or rectified spirit is, therefore, properly preferred. Official Jamaica ginger only should be used; for, while a darker-colored preparation is made when the inferior varieties are substituted, the apparent increase in strength is due to coloring matter, and not to the presence of a larger amount of volatile oil or resin.
The tincture of ginger is a useful carminative, and may often be beneficially added to tonic and purgative infusions or mixtures in debilitated states of the alimentary canal. It is in this country largely used for the preparation of a syrup of ginger, for which purpose, however, the fluidextract is official, and is better even than the strong tincture of the Br. Pharmacopoeia 1885, which was dropped at the 1898 revision.
Dose, eight to forty minims (0.5-2.5 mils).
Off. Prep.—Acidum Sulphuricum Aromaticum, U. S., Br
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Date of monograph revision: 19-Mar-1998; 01-Sep-1998; 09-Apr-2001; 08-Nov-2001; 04-Dec-2003; 25-Jul-2006
Synonyms: Capsic.; Capsici Fructus; Chillies; Espanjanpippuri; Paprikų vaisiai; Paprikový plod; Piment Rouge; Pimentão; Red Pepper; Spanischer Pfeffer; Spansk peppar
NOTE: Ground cayenne pepper of commerce is normally a blend of varieties of capsicum. Paprika is from Capsicum annuum var. longum; it is milder than capsicum.
In Eur. (see ), Jpn, and US.
US also includes capsicum oleoresin (capsicin).
Ph. Eur. 5.5 (Capsicum). The dried ripe fruits of Capsicum annuum var. minimum and small-fruited varieties of C. frutescens. It contains a minimum of 0.4% of total capsaicinoids expressed as capsaicin, calculated with reference to the dried drug. Protect from light.
USP 29 (Capsicum). The dried ripe fruits of Capsicum frutescens, known in commerce as African Chillies, or of C. annuum var. connoides, known in commerce as Tabasco Pepper, or C. annuum var. longum, known in commerce as Louisiana Long Pepper, or of a hybrid between the Honka variety of Japanese Capsicum and the Old Louisiana Sport Capsicum, known in commerce as Louisiana Sport Pepper.
USP 29 (Capsicum Oleoresin). An alcoholic extract of the dried ripe fruits of Capsicum annum var. minimum and small fruited varieties of C. fruiscons (Solanaceae). It contains not less than 8% of total capsaicins. It is a dark red oily liquid. Soluble in alcohol, in acetone, in chloroform, in ether, and in volatile oils; soluble with opalescence in fixed oils. Store in airtight containers.
Capsicum has a carminative action but it is mainly used externally, often in the form of capsicum oleoresin, as a counter-irritant (see Rubefacients and Topical Analgesia, ). It is also included in preparations for the management of cough and cold symptoms. However, preparations of capsicum and capsicum oleoresin can be very irritant. Capsaicin (), the active ingredient of capsicum, is also used in topical preparations in the treatment of painful skin conditions.
Capsicum oleoresin is used in 'pepper sprays' for law enforcement and self defence.
Capsicum is also used in homoeopathic medicine and in cookery.
Effects on the gastrointestinal tract.
The initial response to the ingestion of a hot pepper is a hot or burning sensation in the mouth, which is attributed to the binding of capsaicin to receptors in the oral cavity.1 Casein-containing substances such as milk can reverse this burning sensation, apparently by displacing capsaicin, this being due to their lipophilicity.
Spicy meals have long been associated with gastrointestinal discomfort and ingestion of meals containing 1.5 g of red or black pepper has been shown to cause signs of gastric mucosal damage comparable with those caused by a 625-mg dose of aspirin.2 However, other studies in animals3 and humans4,5 suggest that capsaicin may have a protective effect on gastric mucosa. Ingestion of about 30 g of jalapeño peppers (a capsicum fruit) caused no visible damage to the duodenal or gastric mucosa of 12 healthy subjects6 and daily ingestion of meals containing a total of 3 g of chilli powder did not affect the clinical progress of patients with duodenal ulcers given antacids.7
1. Henkin R. Cooling the burn from hot peppers. JAMA 1991; 266: 2766. PubMed
2. Myers BM, et al. Effect of red pepper and black pepper on the stomach. Am J Gastroenterol 1987; 82: 211–14. PubMed
3. Holzer P. Peppers, capsaicin, and the gastric mucosa. JAMA 1989; 261: 3244–5. PubMed
4. Kang JY, et al. Chili—protective factor against peptic ulcer? Dig Dis Sci 1995; 40: 576–9. PubMed
5. Yeoh KG, et al. Chili protects against aspirin-induced gastroduodenal mucosal injury in humans. Dig Dis Sci 1995; 40: 580–3. PubMed
6. Graham DY, et al. Spicy food and the stomach: evaluation by videoendoscopy. JAMA 1988; 260: 3473–5. PubMed
7. Kumar N, et al. Do chillies influence healing of duodenal ulcer? BMJ 1984; 288: 1803–4. PubMed
References to the toxic effects of 'pepper sprays' containing capsicum oleoresin.
1. Zollman TM, et al. Clinical effects of oleoresin capsicum (pepper spray) on the human cornea and conjunctiva. Ophthalmology 2000; 107: 2186–9. PubMed
2. Chan TC, et al. The effect of oleoresin capsicum "pepper" spray inhalation on respiratory function. J Forensic Sci 2002; 47: 299–304. PubMed
The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.
Argentina: Redol¤; Australia: Shingles Pain Relief¤; Austria: ABC; Capsiplast¤; Chile: Dolorub Capsico; Parche Leon Fortificante; Germany: ABC Warme-Pflaster¤; Capsamol; Dolenon; Hansaplast ABC Warme-Pflaster; Jucurba; Kneipp Rheuma Salbe¤; Rheumaplast N¤; Thermo Burger; Italy: Cerotto Bertelli Arnikos; Dolpyc; Thermogene; United Kingdom: Fiery Jack;
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Drug NomenclatureDrug Definition and DescriptionDrug ProfilePreparations
Synonyms: Ammonii Sulfogyrodalas; Ammonio Sulfoittiolato; Ammonium Bithiolicum; Ammonium Bitumenosulfonicum; Ammonium Bituminosulphonate; Ammonium Ichthosulphonate; Ammonium Sulfobituminosum; Ammonium Sulpho-Ichthyolate; Bithiolate Ammonique; Bithyol; Bituminol; Ichthammolum; Ichthosulphol; Ichthyol; Ichthyolammonium; Ictiol
Read code: y03B4
In Chin., Eur. (see ), Jpn, Pol., and US.
Ph. Eur. 5.0 (Ichthammol). A dense blackish-brown liquid. It is obtained by distillation of certain bituminous schists, sulfonation of the distillate, and neutralisation of the product with ammonia. It contains not less than 4.5% and not more than 7.0% of total ammonia, not less than 10.5% of organically combined sulfur, calculated with reference to the dried substance, and not more than 20% of the total sulfur in the form of sulfates.
Miscible with water and with glycerol; slightly soluble in alcohol, in fatty oils, and in liquid paraffin; forms homogeneous mixtures with wool fat and soft paraffin.
USP 27 (Ichthammol). A reddish-brown to brownish-black viscous fluid with a strong characteristic empyreumatic odour. It is obtained by the destructive distillation of a bituminous schist, sulfonation of the distillate, and neutralisation of the product with ammonia. It yields not less than 10.0% of total sulfur and not less than 2.5% of ammonia. Miscible with water, with glycerol, and with fixed oils and fats. Partially soluble in alcohol and in ether.
Date of monograph revision: 04-Jul-1996; 20-May-1998; 09-Jan-2001; 06-Dec-2001; 16-Jun-2004;
Drug Definition and Description
Ichthammol is incompatible with wool alcohols.
Ichthammol has slight bacteriostatic properties and is used in a wide range of topical preparations, for a variety of skin disorders; it has also been used in suppositories for anorectal disorders. Ichthammol is often used with zinc oxide in medicated bandages for chronic lichenified eczema (). Ichthammol may be slightly irritant to the skin and there have been rare reports of hypersensitivity.
Light Ammonium Bituminosulfonate (Ammoniumbituminosulfonat Hell) is produced from the light distillate fraction of shale oil.
Ammoniumsulfobitol, an ammonium bituminosulfonate similar to ichthammol but with a low sulfur content, is commercially available as Tumenol Ammonium
Ichthammol Ointment USP 27
Ichthammol 100 g
wool fat (Lanolin) 100 g
yellow soft paraffin 800 g
NOTE: Store in airtight containers
Thoroughly incorporate the Ichthammol with the Lanolin, and combine this
mixture with the Petrolatum. Packaging and storage— Preserve in collapsible tubes or in tight containers, and avoid prolonged exposure to temperatures exceeding
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(Ammoniated Mercury). A white amorphous powder or pulverulent pieces; odourless. It is stable in air, but darkens on exposure to light. Insoluble in water and in alcohol; readily soluble in warm hydrochloric, nitric, and acetic acids. Protect from light.
Date of monograph revision: 05-Jul-1996; 20-May-1998; 09-Jan-2001; 06-Dec-2001; 16-Jun-2004;
Ammoniated mercury was formerly used topically in the treatment of skin infections and psoriasis but the use of such mercurial preparations is generally deprecated
Frequent or prolonged application to large areas or to broken skin or mucous membranes can cause
mercury poisoning (see )
and use on infants has produced acrodynia (pink disease)
Ammoniated mercury is also a potent sensitiser and can produce allergic reactions.
Effects on the kidneys
Of 60 patients who were found to have nephrotic syndrome, 32 had used skin-lightening creams
containing 5 to 10% of ammoniated mercury.1Concentrations of mercury in the urine of these patients were up to 250 nanograms/mL compared with a usual upper limit of 80 nanograms/mL. Of 26 patients followed up for up to 2 years, 13 had no remission or response to treatment; 6 of these had used skin lighteners
. Barr RD, et al Nephrotic syndrome in adult Africans in Nairobi. BMJ 1972; 2: 131–4. PubMed
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Date of monograph revision: 28-Jun-1996; 20-May-1998; 09-Jan-2001; 06-Dec-2001; 16-Jun-2004; 17-Jul-2006
Synonyms: Hidroquinona; Hydrochinonum; Hydroquinone; Quinol
Chemical name: 1,4-Benzenediol
Molecular formula: C6H6O2 =110.1
ATC code: D11AX11
Chemical Structure of Hydroquinone
NOTE: Do not confuse with Hydroquinine ().
USP 29 (Hydroquinone). Fine white needles which darken on exposure to light and air. Soluble 1 in 17 of water, 1 in 4 of alcohol, 1 in 51 of chloroform, and 1 in 16.5 of ether. Store in airtight containers. Protect from light.
Adverse Effects, Treatment, and Precautions
Topical hydroquinone may cause transient erythema and a mild burning sensation. High concentrations or prolonged use may produce hyperpigmentation especially on areas of skin exposed to sunlight. Occasionally hypersensitivity has occurred and some recommend skin testing before use. Hydroquinone should not be applied to abraded or sunburnt skin. It should not be used to bleach eyelashes or eyebrows and contact with the eyes should be avoided as it may produce staining and corneal opacities. The systemic effects of hydroquinone and their treatment are similar to those of phenol (see ) but tremors and convulsions may also occur.
Effects on the liver.
Toxic hepatitis in a radiographer was attributed to occupational exposure to hydroquinone fumes from the developing medium used in the darkroom.1 However, it has been pointed out2 that hydroquinone is not volatile under normal conditions of use and that surveillance of 879 people engaged in the manufacture and use of hydroquinone from 1942 to 1990 found no association between toxic hepatitis and hydroquinone exposure.
1. Nowak AK, et al. Darkroom hepatitis after exposure to hydroquinone. Lancet 1995; 345: 1187. PubMed
2. O'Donaghue JL, et al. Hydroquinone and hepatitis. Lancet 1995; 346: 1427–8. PubMed
Effects on the skin.
The incidence of exogenous ochronosis (blue-black hyperpigmentation) in a survey of black South African patients was found to be 15% in males and 42% in females with 69% of affected individuals admitting to using hydroquinone-containing preparations.1 This was considered to be more consistent with a toxic effect of a drug with a low therapeutic index, rather than an idiosyncratic reaction. The data revealed that even preparations with hydroquinone 2% or less with a sunscreen produced ochronosis. Ochronosis usually became apparent after about 6 months of use and, once established, was probably irreversible. Patients may initially use skin lighteners for cosmetic purposes but once ochronosis develops they may fall into the 'skin lightener trap' as they use other hydroquinone preparations to remove the disfigurement.1 The problems caused by over-the-counter skin-lightening creams in countries such as the UK have also been highlighted.2 Reversible brown discoloration of the nails has also been reported after the use of skin lighteners containing hydroquinone.3
1. Hardwick N, et al. Exogenous ochronosis: an epidemiological study. Br J Dermatol 1989; 120: 229–38. PubMed
2. Williams H. Skin lightening creams containing hydroquinone. BMJ 1992; 305: 903–4. PubMed
3. Mann RJ, Harman RRM. Nail staining due to hydroquinone skin-lightening creams. Br J Dermatol 1983; 108: 363–5. PubMed
Uses and Administration
Hydroquinone increases melanin excretion from melanocytes and may also prevent its production. Hydroquinone is used topically as a depigmenting agent for the skin in hyperpigmentation conditions () such as chloasma (melasma), freckles, and lentigines (small macules that resemble freckles). Concentrations of 2 to 4% are commonly used; higher concentrations may be very irritant and increase the risk of ochronosis. It may be several weeks before any effect is apparent but depigmentation may last for 2 to 6 months after stopping. Application of hydroquinone should stop if there is no improvement after 2 months. Hydroquinone should be applied twice daily only to intact skin which should be protected from sunlight to reduce repigmentation. Hydroquinone preparations often include a sunscreen or a sunblocking basis.
Hydroquinone is also used as an antoxidant for ether and in photographic developers.
The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.
Argentina: Claripel; Brazil: Clariderm¤; Claripel; Solaquin; Canada: African Gold¤; Banishing Cream; Eldopaque; Eldoquin; Esoterica Regular; Esoterica Unscented; Jouvence¤; Lustra; Nadinola¤; NeoStrata Canada HQ Plus; Porcelana Nighttime Formula¤; Ultraquin Plain; Chile: Etnoderm; France: Aida¤; Creme des 3 Fleurs d'Orient¤; Hong Kong: Derma-Rx Lightener; Eldopaque; Eldoquin; Solaquin; Israel: Esomed; Italy: Discromil¤; Epocler¤; Malaysia: Eldopaque; Eldoquin; Mexico: Crema Blanca; Eldopaque; Eldoquin; Hidroquin; Melanex; New Zealand: Eldoquin; Singapore: Aida¤; Eldopaque; Eldoquin; Melanex¤; Melanox¤; Polyquin; Solaquin; Spain: Hidroquilaude; Licostrata; Melanasa; Nadona; Pigmentasa; United Kingdom: Eldopaque; Eldoquin; Esoterica¤; Solaquin; United States: Aclaro; Claripel; Eldopaque; Eldoquin; EpiQuin; Esoterica Regular; Lustra; Melanex¤; Melpaque HP¤; Melquin HP¤; Neostrata AHA¤; Porcelana¤; Solaquin; Venezuela: Pharquinon;
The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.
Argentina: Melacler; Melasmax; Neoceuticals Crema Despigmentante de Dia; Neoquin Forte; Neoquin; Neostrata Gel Despigmentante; Solaquin Forte; Tri-Luma; Australia: Superfade; Brazil: Glyquin; Canada: Esoterica; Glyquin XM; Lustra-AF; NeoStrata Canada HQ Plus; NeoStrata HQ; Porcelana Daytime Formula¤; Reversa AHA HQ¤; Skinicles¤; Solaquin Forte; Ultraquin; Viquin Forte; Chile: Alastik¤; Clasifel; D 4¤; Neostrata¤; Neostrata; Tri-Luma; Trio-D¤; France: Melanex Duo¤; Germany: Pigmanorm; Hong Kong: Glyquin; Superfade; Malaysia: Solaquin Forte; Mexico: Clasifel; Nova Derm; Quinoret; Solaquin; Tri-Luma; Portugal: Eutrofic Forte Gel Despigmentante¤; Melanex Duo¤; Singapore: AHA Skin Lightening Gel¤; Glyquin; High Potency Lightening Serum¤; Switzerland: Pigmanorm; United States: Ambi Skin Tone¤; Esoterica Facial and Sunscreen; Glyquin XM; Nuquin HP¤; Porcelana with Sunscreen¤; Solaquin Forte; Solaquin Forte; Tri-Luma; Viquin Forte¤;
USP 29: Hydroquinone Cream; Hydroquinone Topical Solution