MedPath
FDA Product

Denorex Severe Itch

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Denorex Severe Itch

62673-175

Regulatory Information

62673-175

M032

C200263

September 3, 2024

USA

Denorex Severe Itch

HUMAN OTC DRUG LABEL

1

Company Information

790615181

Active Ingredients

TRIETHANOLAMINE SULFATE

Code: MV1V89M17O

Class Code: IACT

PEG/PPG-4/12 DIMETHICONE

Code: JAN3585W85

Class Code: IACT

COCO DIETHANOLAMIDE

Code: 92005F972D

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

AVOCADO OIL

Code: 6VNO72PFC1

Class Code: IACT

CHLOROXYLENOL

Code: 0F32U78V2Q

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

GLYCOL DISTEARATE

Code: 13W7MDN21W

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

PANTHENOL

Code: WV9CM0O67Z

Class Code: IACT

RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE

Code: V176GWC2SR

Class Code: IACT

.ALPHA.-TOCOPHEROL ACETATE

Code: 9E8X80D2L0

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

COAL TAR

Quantity: 0.018 g in 1 mL

Code: R533ESO2EC

Class Code: ACTIB

SUNFLOWER OIL

Code: 3W1JG795YI

Class Code: IACT

PEG-30 LANOLIN

Code: JSB8U68Q2U

Class Code: IACT

TROLAMINE

Code: 9O3K93S3TK

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

QUATERNIUM-80

Code: C29NCR5LBE

Class Code: IACT

MENTHOL

Code: L7T10EIP3A

Class Code: IACT

Active Moieties

COAL TAR

Code: R533ESO2EC

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