MedPath

Hydro-Q

HYDRO-Q (Hydroquinone 4%) Gel

Approved
Approval ID

486781be-498a-49b4-9a80-2dfd02f5e358

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 12, 2023

Manufacturers
FDA

Dermavance Pharmaceuticals

DUNS: 046042475

Products 1

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

Hydroquinone

PRODUCT DETAILS

NDC Product Code30815-0040
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJanuary 12, 2023
Generic NameHydroquinone

INGREDIENTS (7)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HydroquinoneActive
Quantity: 40 mg in 1 g
Code: XV74C1N1AE
Classification: ACTIB
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/12/2023

PRINCIPAL DISPLAY PANEL - 30 g Tube Box

NDC 30815-0040-1

Rx Only

HYDRO-Q4% GEL****®

(Hydroquinone 4%) Gel®

SKIN BLEACHING GEL

DermAvance®
Advanced Skin Care
www.DermAvance.com

30 g

PRINCIPAL DISPLAY PANEL - 30 g Tube Box

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 1/12/2023

PRECAUTIONS

See Warnings

A. Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman, or can affect reproductive capacity.

B. Nursing mothers

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when used by a nursing mother.

C. Pediatric usage

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 1/12/2023

HOW SUPPLIED

HYDRO-Q® (Hydroquinone 4%) Gel is supplied in a 30 g tube.

NDC: 30815-0040-1

Store at controlled room temperature, between 15° and 30°C (59°and 86°F).

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Hydro-Q - FDA Drug Approval Details