FDA label b34c9b12-012b-e6f0-e053-2a95a90a0ae2

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
f50c6e92-9089-4261-9597-200c0a0503ac
SPL ID
b34c9b12-012b-e6f0-e053-2a95a90a0ae2
Version
2
Effective date
2020-11-04
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:19

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. Do not use on to prevent sunburn if product is tan or brown on inflamed or broken skin When using this product mild irritation may occur avoid contact with eyes. If contact occurs. rinse with water. avoid unnecessary sun exposure and usa a sunscreen or protective clothing Stop use and ask a doctor if a gradual blue-black drakening of the skin occurs irritation becomes severe no improvement is seen after 3 months If pregnant or breast feeding consult a health professional before use. Keep out of reach of children In case of accidental ingestion, getmedical help or contact a poison control center.

Reported adverse events (FAERS/openFDA)#

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