OBAGI-C RX System NORMAL-DRY
OBAGI-C RX SYSTEM
2c7b1165-4d43-40b9-a565-8b12dd3d5906
HUMAN PRESCRIPTION DRUG LABEL
Jan 26, 2023
Obagi Cosmeceuticals LLC
DUNS: 790553353
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROQUINONE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC# 62032-535-04
OBAGI®
MEDICAL
OBAGI-C® RX SYSTEM
NORMAL DRY
Skin Intervention Kit
PRECAUTIONS SECTION
PRECAUTIONS
(SeeWARNINGS.)
Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment.
Pregnancy
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 affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.
Nursing Mothers
It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.
Pediatric Use
Safety and effectiveness in children, below the age of 12 years, have not been established.