FDA label 4b795804-92d5-4cd0-9747-8b510e3be5ac

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
9095eba6-6e02-4689-92f3-3ac73cd58f63
SPL ID
4b795804-92d5-4cd0-9747-8b510e3be5ac
Version
3
Effective date
2021-02-19
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:35

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS CAUTION: Hydroquinone 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 medication. Test for skin sensitivity before using Hydroquinone Cream 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 and vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips. Keep out of reach of children. If no bleaching or lightening effect is noted after 2 months of treatment use, Hydroquinone Cream should be discontinued. This product is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn. Sunscreen use is an essential aspect of Hydroquinone therapy because even minimal sunlight sustains melanocytic activity. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation. There are no sunblocking or sunscreening agents in DERMESSE SKIN LIGHTENER and since minimal sunlight exposure may reverse the bleaching effect of this preparation. It should be used only at night or on areas of the body covered by protective clothing. During the daytime, sunblocking or broad spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warning: Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons.

Adverse reactions cross-check#

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

adverse reactions

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

Reported adverse events (FAERS/openFDA)#

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