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Also known as: 483-63-6, N-ethyl-o-crotonotoluidide, Trans-crotamiton, Crotamitone, Eurax, Crotalgin
Molecular Formula
C13H17NO
Molecular Weight
203.28  g/mol
InChI Key
DNTGGZPQPQTDQF-XBXARRHUSA-N
FDA UNII
2EEH27851Y

Crotamiton
1 2D Structure

Crotamiton

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-N-ethyl-N-(2-methylphenyl)but-2-enamide
2.1.2 InChI
InChI=1S/C13H17NO/c1-4-8-13(15)14(5-2)12-10-7-6-9-11(12)3/h4,6-10H,5H2,1-3H3/b8-4+
2.1.3 InChI Key
DNTGGZPQPQTDQF-XBXARRHUSA-N
2.1.4 Canonical SMILES
CCN(C1=CC=CC=C1C)C(=O)C=CC
2.1.5 Isomeric SMILES
CCN(C1=CC=CC=C1C)C(=O)/C=C/C
2.2 Other Identifiers
2.2.1 UNII
2EEH27851Y
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Eurax

2.3.2 Depositor-Supplied Synonyms

1. 483-63-6

2. N-ethyl-o-crotonotoluidide

3. Trans-crotamiton

4. Crotamitone

5. Eurax

6. Crotalgin

7. 124236-29-9

8. Veteusan

9. Crotamitex

10. Eurasil

11. Euraxil

12. Crotamitonum

13. Crotonyl-n-ethyl-o-toluidine

14. Crotamiton, (e)-

15. 2-butenamide, N-ethyl-n-(2-methylphenyl)-

16. (e)-n-ethyl-n-(2-methylphenyl)but-2-enamide

17. (e)-n-ethyl-n-(o-tolyl)but-2-enamide

18. O-crotonotoluidide, N-ethyl-

19. (2e)-n-ethyl-n-(2-methylphenyl)but-2-enamide

20. 2eeh27851y

21. 2-butenamide, N-ethyl-n-(2-methylphenyl)-, (e)-

22. Mfcd00026989

23. 2-butenamide, N-ethyl-n-(2-methylphenyl)-, (2e)-

24. Nsc-758951

25. Crotan

26. Caswell No. 431b

27. Bestloid

28. Crotamitonum [inn-latin]

29. Smr000059145

30. N-ethyl-n-(2-methylphenyl)but-2-enamide

31. Sr-01000759366

32. Einecs 207-596-3

33. Unii-d6s4o4xd0h

34. Epa Pesticide Chemical Code 055701

35. Chebi:31439

36. Brn 3275497

37. N-ethyl-n-(2-methylphenyl)-2-butenamide

38. Unii-2eeh27851y

39. Ai3-17732

40. N-crotonyl-n-ethyl-o-toluidine

41. (e)-crotamiton

42. Crotamiton [usp:inn:ban:jan]

43. Eurax (tn)

44. Prestwick2_000951

45. Prestwick3_000951

46. N-ethylcrotono-o-toluidide

47. N-ethyl-o-crotonotoluidine

48. G 7857

49. N-ethyl- O-crotonotoluidide

50. D6s4o4xd0h

51. Schembl32934

52. Bspbio_000942

53. Bspbio_002722

54. Crotamiton (jan/usp/inn)

55. 3-12-00-01856 (beilstein Handbook Reference)

56. Mls000759489

57. Mls001424003

58. Mls002222307

59. Mls002695895

60. N-ethyl-ortho-crotonotoluidide

61. Spectrum1505271

62. Bpbio1_001038

63. Component Of Eurax (salt/mix)

64. Chembl1200709

65. Gtpl11165

66. Zinc56427

67. N-ethyl-o-crotonotoluidide, 97%

68. Dtxsid101256463

69. Hms1570p04

70. Hms1922p21

71. Hms2051e10

72. Hms2090a10

73. Hms2093o12

74. Hms2097p04

75. Hms2234e16

76. Hms3714p04

77. Pharmakon1600-01505271

78. Bcp13315

79. Hy-b1177

80. N-ethyl-n-(o-tolyl)but-2-enamide

81. Nsc78382

82. Ccg-39402

83. Nsc-78382

84. Nsc758951

85. S1711

86. (e)-n-ethyl-n-o-tolylbut-2-enamide

87. Akos015892746

88. Cs-4730

89. Nc00107

90. Nsc 758951

91. Ncgc00094571-01

92. Ncgc00094571-02

93. Ncgc00094571-03

94. Ncgc00094571-04

95. Ncgc00094571-05

96. As-11641

97. Trans-n-ethyl-n-(o-tolyl)-2-butenamide

98. Sbi-0206763.p001

99. Ab00513973

100. E0814

101. N-ethyl-n-(2-methylphenyl)-2-butenamide #

102. D01381

103. D70888

104. (2e)-n-ethyl-n-(2-methylphenyl)-2-butenamide

105. Ab00513973-09

106. Ab00513973_10

107. 483c636

108. A827519

109. Q-200893

110. Q2439845

111. Sr-01000759366-4

112. Sr-01000759366-6

113. Brd-k13240564-001-01-8

114. Brd-k57179821-001-05-5

115. Brd-k57179821-001-08-9

116. Crotamiton, British Pharmacopoeia (bp) Reference Standard

117. Crotamiton, European Pharmacopoeia (ep) Reference Standard

118. Crotamiton, United States Pharmacopeia (usp) Reference Standard

119. N-ethyl-o-crotonotoluidide; Crotamitone; Crotalgin; Eurasil; Euraxil

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 203.28 g/mol
Molecular Formula C13H17NO
XLogP32.8
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count1
Rotatable Bond Count3
Exact Mass203.131014166 g/mol
Monoisotopic Mass203.131014166 g/mol
Topological Polar Surface Area20.3 Ų
Heavy Atom Count15
Formal Charge0
Complexity235
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameCrotan
PubMed HealthCrotamiton (On the skin)
Drug ClassesScabicide
Drug LabelEurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cety...
Active IngredientCrotamiton
Dosage FormLotion
RouteTopical
Strength10%
Market StatusPrescription
CompanySummers

2 of 4  
Drug NameEurax
Active IngredientCrotamiton
Dosage FormLotion; Cream
RouteTopical
Strength10%
Market StatusPrescription
CompanyRanbaxy

3 of 4  
Drug NameCrotan
PubMed HealthCrotamiton (On the skin)
Drug ClassesScabicide
Drug LabelEurax (crotamiton USP) is a scabicidal and antipruritic agent available as a cream or lotion for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton USP, in a vanishing-cream or emollient-lotion base containing: carbomer-934, cety...
Active IngredientCrotamiton
Dosage FormLotion
RouteTopical
Strength10%
Market StatusPrescription
CompanySummers

4 of 4  
Drug NameEurax
Active IngredientCrotamiton
Dosage FormLotion; Cream
RouteTopical
Strength10%
Market StatusPrescription
CompanyRanbaxy

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Pesticides

Chemicals used to destroy pests of any sort. The concept includes fungicides (FUNGICIDES, INDUSTRIAL); INSECTICIDES; RODENTICIDES; etc. (See all compounds classified as Pesticides.)


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12-Jan-2021
21-Oct-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CREAM;TOPICAL - 10%

USFDA APPLICATION NUMBER - 6927

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DOSAGE - LOTION;TOPICAL - 10%

USFDA APPLICATION NUMBER - 9112

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ABOUT THIS PAGE

Crotamiton Manufacturers

A Crotamiton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crotamiton, including repackagers and relabelers. The FDA regulates Crotamiton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crotamiton 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 Crotamiton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Crotamiton Suppliers

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

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

Crotamiton USDMF

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

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

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

Crotamiton JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Crotamiton Drug Master File in Japan (Crotamiton JDMF) empowers Crotamiton API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Crotamiton JDMF during the approval evaluation for pharmaceutical products. At the time of Crotamiton JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Crotamiton suppliers with JDMF on PharmaCompass.

Crotamiton KDMF

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

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

After submitting a Crotamiton 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 Crotamiton API can apply through the Korea Drug Master File (KDMF).

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

Crotamiton CEP

A Crotamiton CEP of the European Pharmacopoeia monograph is often referred to as a Crotamiton Certificate of Suitability (COS). The purpose of a Crotamiton CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Crotamiton EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Crotamiton to their clients by showing that a Crotamiton CEP has been issued for it. The manufacturer submits a Crotamiton CEP (COS) as part of the market authorization procedure, and it takes on the role of a Crotamiton CEP holder for the record. Additionally, the data presented in the Crotamiton CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Crotamiton DMF.

A Crotamiton CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Crotamiton CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Crotamiton suppliers with CEP (COS) on PharmaCompass.

Crotamiton WC

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

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

Crotamiton GMP

Crotamiton 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 Crotamiton 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 Crotamiton GMP manufacturer or Crotamiton GMP API supplier for your needs.

Crotamiton CoA

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

Crotamiton CoA mostly includes findings from lab analyses of a specific batch. For each Crotamiton 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.

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