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Adverse Effects and Precautions

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Adverse Effects and Precautions 1736 Disinfectants and Preservatives i Amylmetacresoi (BAN, riNN) ..................Preparat ons........ Adverse Effects and Precautions ProprietaryPreparations (details are given in Volume B) The alkyl gallates may cause contact sensitivity and skin Aml!metacreso!; A[ililrnetakrezol: Amylrnet.acreso[; Amylrne.­ AM<InM<;· Multi-ingredient Preparations. Singapore: Esemdent. reactions. ta�resolurn; Amylmetakresol: Amyylirnetakresoli; TaKpe30J1. Effects on the blood. Methaemoglobinaemia associated 6-Pentyl-rn,cresol; S;Methyl.-2-pentylpheooi. Alkyl Gallates with the antoxidants (butylated hydroxyanisole, butylated C1 J1,80= 178.3 hydroxytoluene, and propyl gallate) used to preserve the CAS 1300,94-3. .de Gaiatos alquilo; AnKwnrannalJ:>t. oil in a soybean infant feed fom1ula has been reported.1 UN!! -'-· 05W904P57F: Propyl gallate was suspected of being the most likely cause Dodecyl Gallate because its chemical structure is similar to pyrogallol Pharmacopoeias. In Bur. (see p. vii). (p. 1718.2), a methaemoglobinaemia inducer. Ph. Eur. 8: (Amylmetacresol). A clear or almost clear liquid Dodecilo galatas; Dociecyle,. gallate Dodecylgallat; . de; ..•. I. Nitzan M, et al. Infantile methemoglobinemia caused by food additives. or a solid crystalline mass, colourless or slightly yellow Dodecyi-9Jilat; D(0ec%lis (iallas:. Dodekyyligallaattl; E312; Clin Toxicol 1979; 15: 273-80. when freshly prepared; it darkens or discolours to dark m Galata • de dodecflo; Laury! Gailate; Laurylum Gafikw ; yellow, brownish-yellow, or pink on keeping. F.p. about 22 }logel\vfn rarinar. Preparations degrees. Practically insoluble in water; very soluble in Dodecyi 3,4,5-trihyc;lroxybenzoate. ...................... alcohol and in acetone. Store in non�metallic airtight (details are given in Volume B) C;ul;lje0$=338.4 ProprietaryPreparations containers. Protect from light. CAS ,- 7:166-52-5. Single·ingredient Preparations. China: He Yue (fPiJt);Tian Fu UN!/ �45612DY463 Chu (:7<)[1}]). Profile Pharmacopoeias. In Bur. (see p. vii). Amylmetacresol is a phenolic antiseptic used chiefly as an Ph. Eur. 8: (Dodecyl Gallate). A white or almost white ingredient of lozenges in the treatment of minor infections crystalline powder. M.p. about 96 degrees. Very slightly Alkyldimethylethylbenzyl Ammonium of the mouth and throat. soluble or practically insoluble in water; freely soluble in Chloride alcohol; slightly soluble in dichloromethane. Store in . li nonmetallic containers. Protect from light. C�S • -, 689�6-79-6 • (GZ:Oil alky!(jimethy!ethylbw;il P.r,�p()r� ()n.�........................................... ........................... a111moniurn chioride/,: 85409-23:0 (C !2,C[ 4 alkyldtm ethyie thyl­ Proprietary Preparations (details are given in Volume B) Ethyl Gallate benzyi ammonium chloride) . Single-ingredient Preparations. Irl. : Antiseptic Throat Dropst; UK: (ial�to . de etlfo; 3T."n'<lnnar Antiseptic Throat Lozenges; Antiseptic Throat Lozenges; Ethyi 3,4,5-Hihydroxybe!1ZOate. Profile Throaties Anti-Bacterial Pastilles. C:9H100;"' Alkyldimethylethylbenzyl ammonium chloride is a quater­ 198.2 Arg.: Strepsils Plus; Strepsils; Aus­ _,_ 83lc6 nary ammonium compound with similar properties to Multi�ingredient Preparations. 0\S i -8. tral. : Strepsils Numbing; Strepsils Plust; Strepsils; Austria: Col­ UNH -<.235!6UDDJ L: benzalkonium chloride (alkyldimethylbenzyl ammonium dangin; Neo-Angin; Belg. : Strepsils + Lidocaine; Strepsils Cool chloride; p. 1737.1 ). Mixtures of alkyldimethylethylbenzyl Pharmacopoeias. In Br. Mint; Strepsils Mentholt; Strepsils Vit C; Strepsils; Canad.: ammonium chlorides of different alkyl chain lengths are • Cepacol Sensations Cooling; Cepacol Sensations Sore Throat & BP 2014: (Ethyl Gallate). A white to creamy-white, used as disinfectants, often with benzalkonium chloride. Blocked Nose; Cepacol Sensations Sore Throat & Cough; Cepa­ odourless or almost odourless, crystalline powder. Slightly col Sensations Warming; Cepacol Sensations; Strepsils Cherryf; soluble in water; freely soluble in alcohol and in ether; P. li Strepsils Cool; Strepsils Sore Throat Blocked Nose; Strepsils; practically insoluble in arachis oil. Protect from light. Avoid r,�p�r� ()n.�.. ...................... ..................... Cz. : Neo-Angin; Strepsils Cooling Mint; Strepsils Menthol a contact with metals. ProprietaryPreparations (details are given in Volume B) Eucalyptus; Strepsils Plus; Strepsils Vitamin C; Strepsils; Denm.: Strepsils; Fin.: Med-Angin; Strepsils Menthol; Strepsils; Fr. : Octil Gallate Multi�ingredient Preparations. Canad. : Advance Quat; Brillex; Strepsils Lidocaine; Strepsils Miel-Citron; Strepsils Vitamine C; Cadisan; Cetaintyt; Kemsol; Prevent Xt. Strepsils; Strepsilspray; Ger.: Dobendan Coolt; Dobendan Jun� · E�li; (:)alate de octHo; Octyl . GaHafe: tOCtyle, >;jil!late d'; ior; Dobendan Synergie; Dobendan Warm; Neo�Angin; Gr.: , . Strepsils Plus; Strepsils; Hong Kong: Strepsils Dual Action; O(:tylgallat; O(:tyli> gallas; Oktilo gal�tas; Ok\yigallat; Oktyl� gaH�t; OktyyHgailaatti; .OK t:�nrannar Amba:z:one(BAN, riNN) Strepsils; Hung. : Neo-Angin; Strepsils Menthol and Eucalyptus; : Strepsils Plus; Strepsils Vitamin C; Strepsils; India: Cof Q; Cof­ Octy! 3,4,5-trihydroxyberzoate. Ambatsoni: Arnbazon; t\rnbazona; l1 1nbazonurn; AM6a3oH. sils; Irl. : Strepsils +Plus Anaesthetic; Strepsils Cool; Strepsils C:15Hn0:;=282,3 +Am idinotwdrazonocyclohexa ..J ,4-dien-3-one. rhiosemicar­ Dual Actiont; Strepsils Sore Throat and Blocked Nose; Strepsils CA S•�- 1034-0H. Israel: bazone ·monohydrate. Throat; Strepsils Vitamin C; Strepsils; Strepsils Plus; UN!! :_ 079tiA4S 11. Strepsils with Menthol and Eucalyptus; Strepsils with Vitamin (sH,,N7SJij0=2553 C; Strepsils; Ital.: Benagol Mentolo-Eucaliptolo; Benagol Vita­ Pharmacopoeias. In Eur. (see p. vii). ombazone); CA 'i :_ 539-2 1'9 (anhydrou5 mina C; Benagol; Malaysia: Cherico£; Strepsils Dual Action; Ph. Eur. 8: (Octyl Gallate). A white or almost white (C�mbazone monohydrate;. Strepsils; Neth.: Strepsils Menthol & Eucalyptust; Strepsils crystalline powder. Practically insoluble in water and in Sinaasappel & Vitamine C; Strepsils; NZ: Strepsils Plus Anaes­ ATC"- R02AA O!. 1 thetic; Strepsils with Vitamin C; Strepsils; Philipp.: Strepsils; dichloromethane; freely soluble in alcohol. Store in A TC Vet � flwrwrM1 nonmetallic containers. Protect from light. UN!i ·- Strepsils; Therasil; Pol. : Neo-Angin; Strepsils; Port. : Benagolt; Strepsils; Rus.: Astrasept (Acrpacenr); Coldact Lorpils (Kon)l;aKT Propyl Gallate JloprrHrrc); Gorpils (fOPIIHJIC); Neo-Angin (Heo-AHrrrH); Rinza Profile Lorsept (PHH3a Jlopcern); Strepsils (CrperrcHJic); Strepsils Plus · ·· (Crpencanc Tlmoc); (CrpencHJic c BMra­ BlO;. Galatd de• ropilq:. Propil-g<Jil�t:· Proplkx. · .f!�latas; Strepsils with Vitamin C p Ambazone is an antiseptic that is used in the form Propyle, gallatede; Propylgallat; Propyl•gallat; Propylis galias; MHHOM C); Suprima-Lor (CynprrMa-Jiop); Therasil (Tepacmr); S. lozenges for minor infections of the mouth and pharynx. Afr. : Strepsils Eucalyptus Mentholt; Strepsils Orange-Ct; Prppytu · galusa!');:. Propylum G;!ificurn: PropyyligaHaatti; . Strepsils Plus; Strepsils Soothing Honey & Lemont; Strepsils; nponMrann;>r. · ·· . .. · i Singapore: Cofsils; Robitussin Medicated Lozenges; Strepsils PnJpyl 3,4,5.trihydroxybenzoate. Preparat ons Max Plus; Strepsils; Spain: Strepsils con Vitamina C; Strepsils c,,,H,p,�212.2 ProprietaryPreparations (details are given in Volume B) Lidocaina; Strepsils; Swed. : Strepsils; Switz. : Strepsils with Vit­ CAS -" 121-79-9. amin C; Strepsils; Thai.: Strepsils Butter Menthol Capsicumt; UN/I ;.;_.. 8045NN7V92. Single�ingredient Preparations. Pol. : Faringosept; Rus.: Faringo� Strepsils Maxipluzz; Strepsils Plus Vit C; Strepsils Sugar Freet; sept (<DaprrHrocem); Ukr. : Faringosept (ci>ap:mrrocern). Throatsil Plus; Throatsil; Turk.: Med-Angin; Strepsils C; Strep­ Pharmacopoeias. In Bur. (see p. vii). Also in USNF. sils Mental; Strepsils; UK: Strepsils with Vitamin C; Strepsils; Ph. Eur. 8: (Propyl Gallate). A white or almost white, Ukr. : Coldact Lor Pils (Kon�a.KT Jlop IIHIIc); Neo-Angin (Heo­ crystalline powder. Very slightly soluble in water; freely Aminoquinuride Hydrochloride friNNM) AHnm); Rinza Lorsept (PHH3a Jlopcenr); Strepsils (CrperrcHJic); soluble in alcohol; dissolves in dilute solutions of alkali Strepsils Plus (Crperrcrrnc). hydroxides. Protect from light. Aminoquh•dride, Chlqrhydrate d': Hydro- . USNF 31: (Propyl Gallate). A white crystalline powder with chforidum; Hiorodoruro AM.M- a slight characteristic odour. Slightly soluble in water; freely tl OXI'IHypv1)1arvtr�))oxn opVI,(l.. Amyl phenol . soluble in alcohol. Store in airtight containers. Avoid · I,3;Bis(4-an)ino-2rmethyf..fr.qi.Jinoly!)urea dihydroch!oride. p-tert·f'entylphenol:4-t-Amy lpiJenoL contact with metals. Protect from light. C�,H;oN,0;2HC!=4453 4-(1 , 1-Dl(nethylpropyl)phenof. CAS ,..... '181 I §M (om inoquinurid�J; 5424-37'3(a minoquinur­ ide, hydrochloride), Cl!H,,0-'164.2 Uses U�/li -'- P2YT7 15UiiL 0\S � 80-46'6. The alkyl esters of gallic acid (3,4,5-trihydroxybenzoic acid) VNI! � 6NP9LY.K846. have antoxidant properties and are used as preservatives in pharmaceuticals and cosmetics. Alkyl gallates are also used Profile as antoxidants in foods and are useful in preventing Profile Aminoquinuride hydrochloride is an antiseptic that has deterioration and rancidity of fats and oils. They are used in been used in topical preparations for the treatment of Amylphenol has been used as a phenolic disinfectant and concentrations of 0.001 to 0.1 %. mouth and skin disorders. antiseptic. To improve acceptability and efficacy, the alkyl gallates are frequently used with other antoxidants such as butylated hydroxyanisole or butylated hydroxytoluene Preparations Preparations and with sequestrants and synergists such as citric add and ProprietaryPreparations (details are given in Volume B) ProprietaryPreparations (details are given in Volume B) zinc salts. The alkyl gallates have also been reported to have limited Multi-ingredient Preparations.Austria: Herviros. Mul�·ingredient Preparations. USA: BTK-Plust. antibacterial and antifungal activity. All cross� references refer to entries in Volume A .
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