FDA label d9b4fa27-7b7a-8eab-e053-2995a90a586e

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
21b08c9a-4442-47bc-bf93-738c71b567ce
SPL ID
d9b4fa27-7b7a-8eab-e053-2995a90a586e
Version
4
Effective date
2022-03-08
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:10:00

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

Warnings For external use only. Use only on the advice of a physician. Do not use • On broken or irritated skin. • On children under 12 years of age. • If you are pregnant, nursing or you intend to become pregnant within 3 months of use. Sunburn alert: Limit sun exposure during treatment by using protective clothing or a sunscreen protective agent to avoid re-darkening of the skin. When using this product • A mild transient stinging may occur for people with sensitive skin. • Gradual lightening of the discolored area can be expected in most cases. • Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water. Stop using this product if irritation or rash occurs. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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