FDA label d12e00d9-1373-4c8e-accc-8c24c2dbd14d

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
dfa588ae-1f3a-4a8f-be0f-027b0938fb11
SPL ID
d12e00d9-1373-4c8e-accc-8c24c2dbd14d
Version
2
Effective date
2013-04-23
Source export date
2026-11-06
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/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:42:24

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 when using this product skin irritation may occur some medicines may interact with dimethicone, however, no specific interactions are known at this time Do not use if you are allergic to any ingredients listed if you have sensitive skin and/or are sensitive to Dimethicone do not use if you are pregnant, planning to become pregnant, or breast feeding if you have an open wound, burn, damaged or irritaed skin When using this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling should irritation occur lesson frequency of use avoid unnecessary sun exposure and use a 45 SPF sun screen when going outside Stop use and ask a doctor if any of these severe side effects occur: allergic reaction, irritation become severe i.e. persistant rash, hives, itching, burning, difficulty breathing, swelling

Reported adverse events (FAERS/openFDA)#

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