FDA label 8d3fe2c3-2205-4bf6-aedc-c90d2b27d938

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
675b60c8-573f-4863-9406-cd6caa11a2d1
SPL ID
8d3fe2c3-2205-4bf6-aedc-c90d2b27d938
Version
4
Effective date
2015-02-12
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:30:39

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 and dryness is more likely to occur if you use another topical acne medication. If irritation occurs, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Directions Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Becuase excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor. Inactive ingredients SD Alcohol 40-B, Ethoxydiglycol, Water, Glycerin, Azelaic Acid, Nylon-10/10, Polyacrylate Crosspolymer-6, Propanediol, Betaine, PEG-8/SMDI Copolymer, PEG-12 Dimethicone, Palmitoyl Tripeptide-38, Lens Esculenta (Lentil) Seed Extract, Tetrahexyldecyl Ascorbate, Dipotassium Glycyrrhizinate, Hydroxypropyl Cyclodextrin, Triethanolamine, Fragrance

Reported adverse events (FAERS/openFDA)#

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