FDA label 35001bba-6593-42e7-b1e3-fa3f657fbc2c

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
4d0e1b33-c426-4809-a02e-d5d237f04808
SPL ID
35001bba-6593-42e7-b1e3-fa3f657fbc2c
Version
1
Effective date
2015-08-14
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:46

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 using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if skin irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, use a sunscreen. Inactive Ingredients water (aqua), cyclopentasiloxane, dimethicone, linoleamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, glyceryl stearate, PEG-100 stearate, rosmarinus officinalis (rosemary) leaf extract, melaleuca alternifolia (tea tree) extract, chamomilla recutita (matricaria) flower extract, retinyl palmitate, cetearyl alcohol, polysorbate 60, hexylene glycol, phenoxyethanol, chlorphenesin, glycerin, propylene glycol, methylparaben, benzoic acid, sodium hydroxide, fragrance (parfum).

Reported adverse events (FAERS/openFDA)#

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