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SELENIUM SULFIDE

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

Approved
Approval ID

4c656fee-544a-4279-b77f-ecb77cf6f0c4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 1

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

SELENIUM SULFIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53002-8260
Application NumberANDA089996
Product Classification
M
Marketing Category
C73584
G
Generic Name
SELENIUM SULFIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 11, 2021
FDA Product Classification

INGREDIENTS (9)

SELENIUM SULFIDEActive
Quantity: 2.5 mg in 100 mL
Code: Z69D9E381Q
Classification: ACTIB
BENTONITEInactive
Code: A3N5ZCN45C
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
LAURIC DIETHANOLAMIDEInactive
Code: I29I2VHG38
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT

Drug Labeling Information

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 6/8/2017

OVERDOSAGE

Accidental Oral Ingestion

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.

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SELENIUM SULFIDE - FDA Drug Approval Details