FDA label 687131dc-85e2-498b-90af-ced64ece6718

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
b3d44037-598a-46c9-bc8b-42b0022d88cf
SPL ID
687131dc-85e2-498b-90af-ced64ece6718
Version
2
Effective date
2014-10-14
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:32

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Hydroquinoone is a skin - bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, product should be discontinued and physician consulted. Close patient supervision is recommended. Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The Obagi - C Rx Therapy Night Cream contains sodium metabisulfite, a sulfite that may cause allergic - type reactions including anaphylactic symptoms and life - threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general populationis unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and physician notified immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.