FDA label a4bf6d7d-59b8-489e-8170-1bc69252d27f

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
c296f8dd-bfa0-46aa-8ba3-c56325b2d780
SPL ID
a4bf6d7d-59b8-489e-8170-1bc69252d27f
Version
2
Effective date
2012-03-05
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:04

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

A . 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. B . Test for skin sensitivity before using Hydroquinone Cream by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or 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 4-6 months of treatment use, Hydroquinone Cream should be discontinued. This product is formulated for use as a skinbleaching agent and should not be used for the prevention of sunburn. C . Sunscreen use is an essential aspect of the Hydroquinone therapy because even minimal sunlight exposure 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 sunscreen agents in SLEDGEHAMMER 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. D . Keep this and all medications out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. E . Warning: SLEDGEHAMMER may cause serious allergic-type reactions in certain susceptible persons, such as hives, itching, wheezing, anaphylaxiz, and severe asthma attacks. Discontinue use immediately and contact your physician.

Adverse reactions cross-check#

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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 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.