MedPath
FDA Product

HALOG

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

Basic Information

HALOG

10631-096

Regulatory Information

10631-096

NDA017824

C73594

July 29, 2019

USA

(Halcinonide Ointment, USP) 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Rx only

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

146974886

Active Ingredients

HALCINONIDE

Quantity: 1 mg in 1 g

Code: SI86V6QNEG

Class Code: ACTIB

POLYETHYLENE GLYCOL 300

Code: 5655G9Y8AQ

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

POLYETHYLENE GLYCOL 1450

Code: OJ4Z5Z32L4

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

BUTYLATED HYDROXYTOLUENE

Code: 1P9D0Z171K

Class Code: IACT

MINERAL OIL

Code: T5L8T28FGP

Class Code: IACT

Active Moieties

HALCINONIDE

Code: SI86V6QNEG

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