FDA.reportPublic FDA data

FDA label 48be395f-c5ed-664e-e054-00144ff88e88

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
e8e1f1c5-c5e0-4cde-a933-7299c845d06c
SPL ID
48be395f-c5ed-664e-e054-00144ff88e88
Version
2
Effective date
2017-02-17
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:09

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 Using other topical acne medications at the same time or immediately following use of this product may cause dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Other Information You may report a serious adverse reaction to this product to: BABOR Cosmetics America Corp. 931 Village Boulevard - Suite 905-359 West Palm Beach, FL 33409-1939

Reported adverse events (FAERS/openFDA)#

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