FDA label 2003828a-deef-4adc-a8dc-e13b3e4977ca

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
c538dc65-ac9a-431d-b13f-6028cf876e5e
SPL ID
2003828a-deef-4adc-a8dc-e13b3e4977ca
Version
2
Effective date
2015-07-01
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:25:32

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 1. Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication. 2. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation or vesicle formation occurs. Use of NUQUIN ® HP 4% CREAM in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS ). If no improvement is seen after two months of treatment, use of this product should be discontinued. 3. Sunscreen use is an essential aspect of the hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in NUQUIN ® HP 4% CREAM provide the necessary sun protection during the process of skin bleaching. After clearing and during the maintenance period of therapy, sun exposure should be avoided on the bleached skin by the application of a suncreen or a sunblock agent, or protective clothing to prevent the skin from repigmenting. 4. 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 population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 5. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. 6. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact a physician. A bitter taste and antiseptic effect may occur if applied to the lips.

Adverse reactions cross-check#

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

adverse reactions

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