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    Also known as: 637-58-1, Pramoxine hcl, Pramocaine hydrochloride, Prax lotion, Tronothane, Pramocaine (hydrochloride)
    Molecular Formula
    C17H28ClNO3
    Molecular Weight
    329.9  g/mol
    InChI Key
    SYCBXBCPLUFJID-UHFFFAOYSA-N
    FDA UNII
    88AYB867L5
    Pramoxine Hydrochloride
    Pramocaine Hydrochloride is the hydrochloride salt form of pramoxine, a morpholine derivative with local anesthetic property. Pramocaine hydrochloride decreases the permeability of the neuronal membrane to sodium ions by reversibly binding to and inhibiting voltage-gated sodium channels. This results in stabilization of the membrane and, thereby inhibiting the ionic fluxes required for membrane depolarization, hence resulting in the failure to initiate a propagated action potential and subsequent conduction blockade.
    1 2D Structure

    Pramoxine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[3-(4-butoxyphenoxy)propyl]morpholine;hydrochloride
    2.1.2 InChI
    InChI=1S/C17H27NO3.ClH/c1-2-3-12-20-16-5-7-17(8-6-16)21-13-4-9-18-10-14-19-15-11-18;/h5-8H,2-4,9-15H2,1H3;1H
    2.1.3 InChI Key
    SYCBXBCPLUFJID-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCOC1=CC=C(C=C1)OCCCN2CCOCC2.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    88AYB867L5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-(3-(4-butoxyphenoxy)propyl)morpholine

    2. 4-(3-(p-butoxyphenoxy)propyl)morpholine

    3. Balsabit

    4. Fleet Pain Relief

    5. Itch-x

    6. Pramegel

    7. Pramocaine

    8. Pramocaine Hydrochloride

    9. Pramox

    10. Pramoxine

    11. Prax

    12. Proctofoam

    13. Tronolane

    14. Tronothane

    2.3.2 Depositor-Supplied Synonyms

    1. 637-58-1

    2. Pramoxine Hcl

    3. Pramocaine Hydrochloride

    4. Prax Lotion

    5. Tronothane

    6. Pramocaine (hydrochloride)

    7. Morpholine, 4-[3-(4-butoxyphenoxy)propyl]-, Hydrochloride

    8. 4-[3-(4-butoxyphenoxy)propyl]morpholine Hydrochloride

    9. Nsc-25573

    10. 4-(3-(4-butoxyphenoxy)propyl)morpholine Hydrochloride

    11. Pramoxine Hydrochloride [usp]

    12. Mls000028604

    13. Tronolane

    14. 88ayb867l5

    15. 4-(3-(p-butoxyphenoxy)propyl)morpholine Hydrochloride

    16. 4-[3-(4-butoxyphenoxy)propyl]morpholine;hydrochloride

    17. 637-58-1 (hcl)

    18. Morpholine, 4-(3-(4-butoxyphenoxy)propyl)-, Hydrochloride

    19. Smr000058670

    20. Dsstox_cid_27757

    21. Dsstox_rid_82534

    22. Dsstox_gsid_47777

    23. Pramoxine Hydrochloride (usp)

    24. Tronothane Hydrochloride

    25. Proctofoam-ns

    26. Hsdb 7220

    27. Ncgc00016529-01

    28. Cas-637-58-1

    29. Einecs 211-293-1

    30. Nsc 25573

    31. 4-[3-(p-butoxyphenoxy)propyl]morpholine Hydrochloride

    32. Unii-88ayb867l5

    33. Sr-01000000243

    34. Pramoxine, Hcl

    35. Tronothane (tn)

    36. Prestwick_1044

    37. P-butoxyphenyl Gamma-morpholinopropyl Ether Hydrochloride

    38. Gamma-morpholinopropyl 4-n-butoxyphenyl Ether Hydrochloride

    39. Opera_id_1593

    40. Pramoxine Hcl [inci]

    41. Mls002222295

    42. Schembl180542

    43. Spectrum1501139

    44. Amy585

    45. Chebi:8358

    46. Chembl1201171

    47. Dtxsid2047777

    48. Morpholine, 4-(3-(p-butoxyphenoxy)propyl)-, Hydrochloride

    49. Hms1570o13

    50. Hms1921j07

    51. Pharmakon1600-01501139

    52. Hy-b1319

    53. Nsc25573

    54. Pramoxine Hydrochloride [mi]

    55. Tox21_110477

    56. Mfcd00054323

    57. Nsc757847

    58. S4092

    59. Pramoxine Hydrochloride [hsdb]

    60. Akos015895041

    61. Tox21_110477_1

    62. Ac-2094

    63. Ccg-212937

    64. Cs-4643

    65. Nsc-757847

    66. Pramoxine Hydrochloride [vandf]

    67. Wln: T6n Dotj A3or Do4 &gh

    68. Pramocaine Hydrochloride [mart.]

    69. Pramoxine Hydrochloride [usp-rs]

    70. Ncgc00016529-07

    71. Ncgc00094907-01

    72. Ncgc00094907-02

    73. Ncgc00094907-03

    74. Pramocaine Hydrochloride [who-dd]

    75. As-12691

    76. Db-054541

    77. Ft-0603501

    78. Pramoxine Hydrochloride [orange Book]

    79. Sw197114-3

    80. Vu0239834-5

    81. D00739

    82. D97624

    83. Epifoam Component Pramoxine Hydrochloride

    84. Pramoxine Hydrochloride [usp Monograph]

    85. A834509

    86. Pramosone Component Pramoxine Hydrochloride

    87. Pramoxine Hydrochloride Component Of Epifoam

    88. Pramoxine Hydrochloride, Analytical Standard, >=98%

    89. Q-100732

    90. Sr-01000000243-3

    91. Pramoxine Hydrochloride Component Of Pramosone

    92. Proctofoam Hc Component Pramoxine Hydrochloride

    93. Q27269918

    94. 4-[3-(4-butoxyphenoxy)propyl]morpholin-4-ium;chloride

    95. Pramoxine Hydrochloride Component Of Proctofoam Hc

    96. P-butoxyphenyl .gamma.-morpholinopropyl Ether Hydrochloride

    97. .gamma.-morpholinopropyl 4-n-butoxyphenyl Ether Hydrochloride

    98. 4-[3-(4-butoxyphenoxy)propyl]morpholine Hydrochloride (1:1)

    99. Morpholine, 4-[3-(p-n-butoxyphenoxy )propyl]-, Hydrochloride

    100. 4-n-butoxyphenyl.gamma.-morpholinopropyl Ether Hydrochloride

    101. Morpholine, 4-[3-(4-butoxyphenoxy)propyl]-, Hydrochloride (1:1)

    102. 4-[3-(4-butoxyphenoxy)propyl]morpholine Chloride;pramocaine Hydrochloride

    103. Pramoxine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    104. Pramoxine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 329.9 g/mol
    Molecular Formula C17H28ClNO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count9
    Exact Mass329.1757714 g/mol
    Monoisotopic Mass329.1757714 g/mol
    Topological Polar Surface Area30.9 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity248
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Anesthetic (local)

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1376

    Indicated for the symptomatic relief of: hemorrhoids, anorectal inflammation and anorectal pain. (these medications /including pramoxine/ are effective when applied to the anal, periana, or anorectal areas. However, they are not likely to relieve symptoms associated with conditions confined to the rectum, which lacks sensory nerve fibers.) /Included in US product labeling/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 153

    Pramoxine preparations are used topically for the temporary relief of pain and itching associated with dermatoses; rashes due to poison ivy, poison oak, poison sumac, insect bites; minor burns; anogenital pruritus or irritation; and fissures; or hemorrhoids. The drug should not be used for bronchoscopy or gastroscopy since it is not sufficiently potent to abolish the gag reflex.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    4.2 Drug Warning

    Local effects, such as burning or stinging, may occur following topical application of pramoxine. The drug has a low index of sensitization, and cross-sensitization with other local anesthetics is unlikely.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    Topical pramoxine preparations should not be used in or near the eyes or nose.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    The preparations should not be applied to extensive areas of skin and are not for prolonged use. The aerosol foam for rectal administration should not be used longer than 4 consecutive weeks.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    If pramoxine preparations are used for self-medication and the condition worsens or symptoms persist for prolonged periods (e.g., for more than 7 days) or clear and occur again within a few days, the drug should be discontinued and a physician consulted.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    If rectal bleeding occurs during use of pramoxine for pain and itching of hemorrhoids or if erythema, irritation, swelling, or pain occurs during use of pramoxine preparations, the drug should be discontinued and a physician consulted.

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3414

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anesthetics, Local

    Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

    5.2 Absorption, Distribution and Excretion

    ... These agents are readily absorbed through mucous membranes into the systemic circulation. The rate of absorption is influenced by the vascularity or rate of blood flow at the site of application, the total dosage (concentration and volume) administered, and the duration of exposure. ... /Local anesthetics/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 154

    5.3 Mechanism of Action

    Local anesthetics block both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade. /Local anesthetics/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 154

    API Reference Price

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PRAMOXINE HYDROCHLORIDE\/USP -BATCH NO:PMXD\/224012 -MFG DT:SEPTEMBER 2024 -RETEST DT :AUG 2029","address":"RAY HOUSE, HIG 2000,,MOTHER DIARY","city":"BANGALORE,KARNATAKA","supplier":"R L FINE CHEM","supplierCountry":"INDIA","foreign_port":"DALLAS","customer":"TO THE ORDER OF","customerCountry":"UNITED STATES","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"165","totalValueFC":"81381.4","currency":"USD","unitRateINR":13676.39026,"date":"08-Oct-2024","totalValueINR":"6838195.13","totalValueInUsd":"81381.4","indian_port":"Bangalore ICD","hs_no":"29420090","bill_no":"4663187","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore ICD","supplierAddress":"RAY HOUSE, HIG 2000,,MOTHER DIARY, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"PHARMACEUTICAL RAW MATERIAL \/ BULK DRUGS- PRAMOXINE HYDROCHLORIDE USP","address":"309 HARIKRUPA TOWER NR.OLD-","city":"AHMEDABAD","supplier":"JAI RADHE SALES","supplierCountry":"INDIA","foreign_port":"GUATEMALA CITY","customer":"TO THE ORDER OF","customerCountry":"GUATEMALA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"613","totalValueFC":"445.6","currency":"USD","unitRateINR":37440,"date":"26-Oct-2024","totalValueINR":"37440","totalValueInUsd":"445.6","indian_port":"Ahmedabad Air","hs_no":"29211190","bill_no":"5152715","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"GUATEMALA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"309 HARIKRUPA TOWER NR.OLD-, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"PHARMACEUTICAL BULK DRUG - 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    02-Feb-2022
    29-Nov-2024
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    ABOUT THIS PAGE

    Pramoxine Hydrochloride Manufacturers

    A Pramoxine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramoxine Hydrochloride, including repackagers and relabelers. The FDA regulates Pramoxine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramoxine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Pramoxine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pramoxine Hydrochloride Suppliers

    A Pramoxine Hydrochloride supplier is an individual or a company that provides Pramoxine Hydrochloride active pharmaceutical ingredient (API) or Pramoxine Hydrochloride finished formulations upon request. The Pramoxine Hydrochloride suppliers may include Pramoxine Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Pramoxine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Pramoxine Hydrochloride USDMF

    A Pramoxine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Pramoxine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Pramoxine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Pramoxine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Pramoxine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Pramoxine Hydrochloride USDMF includes data on Pramoxine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pramoxine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Pramoxine Hydrochloride suppliers with USDMF on PharmaCompass.

    Pramoxine Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Pramoxine Hydrochloride Drug Master File in Korea (Pramoxine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pramoxine Hydrochloride. The MFDS reviews the Pramoxine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Pramoxine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Pramoxine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pramoxine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Pramoxine Hydrochloride suppliers with KDMF on PharmaCompass.

    Pramoxine Hydrochloride WC

    A Pramoxine Hydrochloride written confirmation (Pramoxine Hydrochloride WC) is an official document issued by a regulatory agency to a Pramoxine Hydrochloride manufacturer, verifying that the manufacturing facility of a Pramoxine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pramoxine Hydrochloride APIs or Pramoxine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Pramoxine Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Pramoxine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Pramoxine Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pramoxine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pramoxine Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Pramoxine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Pramoxine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pramoxine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Pramoxine Hydrochloride suppliers with NDC on PharmaCompass.

    Pramoxine Hydrochloride GMP

    Pramoxine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Pramoxine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pramoxine Hydrochloride GMP manufacturer or Pramoxine Hydrochloride GMP API supplier for your needs.

    Pramoxine Hydrochloride CoA

    A Pramoxine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Pramoxine Hydrochloride's compliance with Pramoxine Hydrochloride specifications and serves as a tool for batch-level quality control.

    Pramoxine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Pramoxine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Pramoxine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramoxine Hydrochloride EP), Pramoxine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramoxine Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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