Hydro-Q
HYDRO-Q (Hydroquinone 4%) Gel
486781be-498a-49b4-9a80-2dfd02f5e358
HUMAN PRESCRIPTION DRUG LABEL
Jan 12, 2023
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
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
PRECAUTIONS SECTION
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
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).