RAYO ACTIVE HEAT

Approved

Approval ID

09e4a36b-020a-c5b1-e063-6394a90a3e31

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 10, 2024

Manufacturers

FDA

Quimicas Handal de Centroamerica SA de CV

DUNS: 850638768

Products 10

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

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1606

Application NumberM017

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (6)

PETROLATUMInactive

Quantity: 1 g in 1 g

Code: 4T6H12BN9U

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

TURPENTINEInactive

Quantity: 1 g in 1 g

Code: XJ6RUH0O4G

Classification: IACT

EUCALYPTOLInactive

Quantity: 1 g in 1 g

Code: RV6J6604TK

Classification: IACT

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

CHAMOMILEInactive

Quantity: 1 g in 1 g

Code: FGL3685T2X

Classification: IACT

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1620

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (6)

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

EUCALYPTOLInactive

Quantity: 1 g in 1 g

Code: RV6J6604TK

Classification: IACT

PETROLATUMInactive

Quantity: 1 g in 1 g

Code: 4T6H12BN9U

Classification: IACT

CHAMOMILEInactive

Quantity: 1 g in 1 g

Code: FGL3685T2X

Classification: IACT

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

TURPENTINEInactive

Quantity: 1 g in 1 g

Code: XJ6RUH0O4G

Classification: IACT

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1594

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (9)

FD&C BLUE NO. 1Inactive

Quantity: 1 g in 1 g

Code: H3R47K3TBD

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive

Quantity: 1 g in 1 g

Code: 0A5MM307FC

Classification: IACT

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

POLYSORBATE 80Inactive

Quantity: 1 g in 1 g

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

TROLAMINEInactive

Quantity: 1 g in 1 g

Code: 9O3K93S3TK

Classification: IACT

ISOPROPYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: ND2M416302

Classification: IACT

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1600

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (9)

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

POLYSORBATE 80Inactive

Quantity: 1 g in 1 g

Code: 6OZP39ZG8H

Classification: IACT

FD&C BLUE NO. 1Inactive

Quantity: 1 g in 1 g

Code: H3R47K3TBD

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive

Quantity: 1 g in 1 g

Code: 0A5MM307FC

Classification: IACT

TROLAMINEInactive

Quantity: 1 g in 1 g

Code: 9O3K93S3TK

Classification: IACT

ISOPROPYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: ND2M416302

Classification: IACT

MENTHOL, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1601

Application NumberM017

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, METHYL SALICYLATE

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (8)

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

MICROCRYSTALLINE WAXInactive

Quantity: 1 g in 1 g

Code: XOF597Q3KY

Classification: IACT

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

MINERAL OILInactive

Quantity: 1 g in 1 g

Code: T5L8T28FGP

Classification: IACT

CETYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: 936JST6JCN

Classification: IACT

POLYOXYL 20 CETOSTEARYL ETHERInactive

Quantity: 1 g in 1 g

Code: YRC528SWUY

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

METHYL SALICYLATEActive

Quantity: 1 g in 1 g

Code: LAV5U5022Y

Classification: ACTIB

MENTHOL, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1599

Application NumberM017

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, METHYL SALICYLATE

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (8)

MINERAL OILInactive

Quantity: 1 g in 1 g

Code: T5L8T28FGP

Classification: IACT

CETYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: 936JST6JCN

Classification: IACT

POLYOXYL 20 CETOSTEARYL ETHERInactive

Quantity: 1 g in 1 g

Code: YRC528SWUY

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

METHYL SALICYLATEActive

Quantity: 1 g in 1 g

Code: LAV5U5022Y

Classification: ACTIB

MICROCRYSTALLINE WAXInactive

Quantity: 1 g in 1 g

Code: XOF597Q3KY

Classification: IACT

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1605

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (5)

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

TURPENTINEInactive

Quantity: 1 g in 1 g

Code: XJ6RUH0O4G

Classification: IACT

EUCALYPTOLInactive

Quantity: 1 g in 1 g

Code: RV6J6604TK

Classification: IACT

PETROLATUMInactive

Quantity: 1 g in 1 g

Code: 4T6H12BN9U

Classification: IACT

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1609

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (9)

POLYSORBATE 80Inactive

Quantity: 1 g in 1 g

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

TROLAMINEInactive

Quantity: 1 g in 1 g

Code: 9O3K93S3TK

Classification: IACT

ISOPROPYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: ND2M416302

Classification: IACT

FD&C BLUE NO. 1Inactive

Quantity: 1 g in 1 g

Code: H3R47K3TBD

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive

Quantity: 1 g in 1 g

Code: 0A5MM307FC

Classification: IACT

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

MENTHOL, CAMPHOR

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1612

Application NumberM012

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, CAMPHOR

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (6)

TURPENTINEInactive

Quantity: 1 g in 1 g

Code: XJ6RUH0O4G

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

EUCALYPTOLInactive

Quantity: 1 g in 1 g

Code: RV6J6604TK

Classification: IACT

PETROLATUMInactive

Quantity: 1 g in 1 g

Code: 4T6H12BN9U

Classification: IACT

CHAMOMILEInactive

Quantity: 1 g in 1 g

Code: FGL3685T2X

Classification: IACT

CAMPHOR (SYNTHETIC)Active

Quantity: 1 g in 1 g

Code: 5TJD82A1ET

Classification: ACTIB

MENTHOL, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code83033-1595

Application NumberM017

Product Classification

Marketing Category

C200263

Generic Name

MENTHOL, METHYL SALICYLATE

Product Specifications

Route of AdministrationTOPICAL

Effective DateJanuary 10, 2024

FDA Product Classification

INGREDIENTS (8)

MICROCRYSTALLINE WAXInactive

Quantity: 1 g in 1 g

Code: XOF597Q3KY

Classification: IACT

WATERInactive

Quantity: 1 g in 1 g

Code: 059QF0KO0R

Classification: IACT

MINERAL OILInactive

Quantity: 1 g in 1 g

Code: T5L8T28FGP

Classification: IACT

CETYL ALCOHOLInactive

Quantity: 1 g in 1 g

Code: 936JST6JCN

Classification: IACT

POLYOXYL 20 CETOSTEARYL ETHERInactive

Quantity: 1 g in 1 g

Code: YRC528SWUY

Classification: IACT

MENTHOLActive

Quantity: 1 g in 1 g

Code: L7T10EIP3A

Classification: ACTIB

METHYLISOTHIAZOLINONEInactive

Quantity: 1 g in 1 g

Code: 229D0E1QFA

Classification: IACT

METHYL SALICYLATEActive

Quantity: 1 g in 1 g

Code: LAV5U5022Y

Classification: ACTIB

AI-Powered Research

Premium Access

RAYO ACTIVE HEAT

Products 10

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (6)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (6)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

MENTHOL, METHYL SALICYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (8)

MENTHOL, METHYL SALICYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (8)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (5)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

MENTHOL, CAMPHOR

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (6)

MENTHOL, METHYL SALICYLATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (8)

MedPath

Product

Company

Legal