MedPath

E2 hand wash

Approved
Approval ID

a40afa46-a07d-f864-e053-2a95a90aef8a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 1, 2025

Manufacturers
FDA

Horizon Tool Inc.

DUNS: 602012460

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

E2 Sanitizing Hand Soap

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-6400
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
E2 Sanitizing Hand Soap
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 6, 2025
FDA Product Classification

INGREDIENTS (8)

DECYL GLUCOSIDEInactive
Quantity: 12.5 mL in 500 mL
Code: Z17H97EA6Y
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Quantity: 0.0005 mL in 500 mL
Code: 5OCF3O11KX
Classification: IACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTUREInactive
Quantity: 3.75 mL in 500 mL
Code: 15O9QS218W
Classification: IACT
WATERInactive
Quantity: 468.45 mL in 500 mL
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYLCELLULOSEInactive
Quantity: 4 mL in 500 mL
Code: T4V6TWG28D
Classification: IACT
CITRIC ACIDInactive
Quantity: 0.0025 mL in 500 mL
Code: 2968PHW8QP
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 500 mL
Code: F5UM2KM3W7
Classification: ACTIB
GLYCERINInactive
Quantity: 10 mL in 500 mL
Code: PDC6A3C0OX
Classification: IACT

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-1002
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Quantity: 282 mL in 1021.95 mL
Code: 059QF0KO0R
Classification: IACT
FRAGRANCE CLEAN ORC0600327Inactive
Quantity: 0.044 mL in 1021.95 mL
Code: 329LCV5BTF
Classification: IACT
GLYCERINInactive
Quantity: 14.8 mL in 1021.95 mL
Code: PDC6A3C0OX
Classification: IACT
RAPIDGEL EZ1Inactive
Quantity: 9.7 mL in 1021.95 mL
Code: 33JH4A7R2K
Classification: IACT
ALCOHOLActive
Quantity: 715.4 mL in 1021.95 mL
Code: 3K9958V90M
Classification: ACTIB

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-3001
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 73 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT

E2 Sanitizing Hand Soap

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-6300
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
E2 Sanitizing Hand Soap
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (8)

COCAMIDOPROPYL BETAINEInactive
Quantity: 6 mL in 100 mL
Code: 5OCF3O11KX
Classification: IACT
HYDROXYETHYLCELLULOSEInactive
Quantity: 0.8 mL in 100 mL
Code: T4V6TWG28D
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Quantity: 88.69 mL in 100 mL
Code: 059QF0KO0R
Classification: IACT
DECYL GLUCOSIDEInactive
Quantity: 1.5 mL in 100 mL
Code: Z17H97EA6Y
Classification: IACT
GLYCERINInactive
Quantity: 2 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 mg in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTUREInactive
Quantity: 0.75 mL in 100 mL
Code: 15O9QS218W
Classification: IACT

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-3000
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

ALCOHOLActive
Quantity: 73 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-2001
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT
ALCOHOLActive
Quantity: 80 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-1000
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

ALCOHOLActive
Quantity: 73 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT

ALOCOHL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-2100
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALOCOHL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 80 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-5000
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (6)

WATERInactive
Quantity: 282 mL in 1021.95 mL
Code: 059QF0KO0R
Classification: IACT
RAPIDGEL EZ1Inactive
Quantity: 9.7 mL in 1021.95 mL
Code: 33JH4A7R2K
Classification: IACT
FRAGRANCE CLEAN ORC0600327Inactive
Quantity: 0.044 mL in 1021.95 mL
Code: 329LCV5BTF
Classification: IACT
DENATONIUM BENZOATE ANHYDROUSInactive
Quantity: 0.006 mL in 1021.95 mL
Code: M5BA6GAF1O
Classification: IACT
GLYCERINInactive
Quantity: 14.8 mL in 1021.95 mL
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLActive
Quantity: 715.4 mL in 1021.95 mL
Code: 3K9958V90M
Classification: ACTIB

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code74683-2000
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification

INGREDIENTS (4)

ALCOHOLActive
Quantity: 80 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
HYDROGEN PEROXIDEInactive
Quantity: 0.125 mL in 100 mL
Code: BBX060AN9V
Classification: IACT
GLYCERINInactive
Quantity: 1.45 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/18/2022

Package Label - Principal Display Panel

3785.5 mL NDC: 74683-6400-1

3785.4 mL NDC: 74683-6300-1 3785.4 mL label

3785.41 mL NDC: 74683-2001-2

3785.41 mL label

473 mL NDC: 74683-2001-1

473 mL front label

473 mL rear label

118 mL NDC: 74683-5001-4

118 mL label

250 mL NDC: 74683-5001-3

250 mL label

59 mL NDC: 74683-5001-2

59mL Label

473 mL NDC: 74683-5001-1

473 mL label

250 mL NDC: 74683-1002-1

250 mL label

3785.4 mL NDC: 74683-6200-3

3785.4 mL label

250 mL NDC: 7463-6200-2

250 mL label

3785.4 mL NDC: 74683-6200-1

3785.4 mL label

3785.4 mL NDC: 74683-6000-1 3785.4 mL label

59 mL NDC: 74683-2100-1 59ml label

946.35 mL NDC: 74683-3001-1 946.35 ml label

262 mL NDC: 74683-2500-1 262 mL wipe label

1892.71 mL NDC: 74683-5000-9 1892.71 mL label

208.2 L NDC: 74683-5000-8 208.2 L label

946.35 mL NDC: 74683-5000-7 946.35 mL rear label

946.35 mL NDC: 74683-5000-7 946.35 mL front label

473 mL NDC: 74683-5000-6 473 mL label

3785.41 mL NDC: 74683-5000-5 3785.41 mL 4cc label

3785.41 mL NDC: 74683-5000-4 3785.41 mL 10cc label

354.8 mL NDC: 74683-5000-3 354.8 mL label

236 mL NDC: 74683-5000-2 236 mL label

118 mL NDC: 74683-5000-1 118 mL label

118 mL NDC: 74683-4000-1

118 mL Tiger gel label

3 mL NDC 74683-3000-8

3mL gel rear

3 mL NDC 74683-3000-8

3mL gel front

3 mL NDC 74683-3000-9

3mL gel rear

3 mL NDC 74683-3000-9

3mL gel front

3785.41 mL NDC 74683-3000-7

3785.41mL gel

3785.41 mL NDC 74683-3000-6

3785.41mL gel

3785.41 mL NDC 74683-3000-5

3785.41mL gel

1892.71 mL NDC 74683-3000-4

1892.71mL gel

946.35 mL NDC 74683-3000-3

946.35mL gel rear

946.35 mL NDC 74683-3000-3

946.35mL gel front

118 mL NDC 74683-3000-2

118mL gel

59 mL NDC 74683-3000-1

59mL gel rear

59 mL NDC 74683-3000-1

59mL gel front

473 mL NDC 74683-1000-9

473mL gel TenSan

236 mL NDC 74683-1000-8 236mL gel TenSan

059 mL NDC: 74683-1000-6

59 mL gel front

059 mL NDC: 74683-1000-6

59 mL gel rear

74683-1000-7

118 mL gel

236 mL NDC: 74683-2000-1 236mL gel473 mL NDC: 74683-1000-2

473mL gel

946.35 mL NDC: 74683-1000-3 946.35 mL front label946.35 mL NDC: 74683-1000-3

946.35mL gel rear

1892.71 mL NDC: 74683-1000-4

1892.71mL gel3785.41 mL NDC: 74683-1000-5

3785.41mL gel473 mL NDC: 74683-2000-1

473mL liquid front473 mL NDC: 74683-2000-1

473mL liquid rear946.35 mL NDC: 74683-2000-2

946.35mL liquid front946.35 mL NDC: 74683-2000-2

946.35mL liquid rear1892.71 mL NDC: 74683-2000-3

1892.71mL liquid3785.41 mL NDC: 74683-2000-4

3785.41mL liquid

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E2 hand wash - FDA Drug Approval Details