FDA.reportPublic FDA data

FDA label b34c8abf-9178-a27a-e053-2a95a90ac4a6

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
b303b837-fc01-4acd-a860-30555cf86c1f
SPL ID
b34c8abf-9178-a27a-e053-2a95a90ac4a6
Version
2
Effective date
2020-11-04
Source export date
2026-08-17
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/559e90e291f706011ac4a15e81427bf26ca36e5d0b9d84e84d297d7c5834404b/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:00:37

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 on inflamed or broken skin if product is tan or brown When using this product mild irritation may occur avoid contact with eyes. If contact occurs, rinse with water. avoid unnecessary sun exposure and use a sunscreen or protective clothing Stop use and consult a doctor if a gradual blue-black darkening of the skin occurs if irritation becomes severe if no improvement is seen after 3 months If pregnant or breast feeding ask a health professional before use. Keep out of reach of children