FDA label a8b440d1-7efe-3699-e053-2a95a90a7a48

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: 8fa82d96-d558-420b-b35d-6450f0148339
SPL ID: a8b440d1-7efe-3699-e053-2a95a90a7a48
Version: 4
Effective date: 2020-06-22
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:22:50

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		a8b440d1-7efe-3699-e053-2a95a90a7a48	id
spl set id		8fa82d96-d558-420b-b35d-6450f0148339	set_id

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 Directions Clean the skin thoroughly before applying. Cover the entire affected area with a thin layer 1 to 3 times daily. Avoid contact with eyes Because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2 or 3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Inactive Ingredients: Acrylates/C10-30 Alkyl acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Disodium Phosphate, Ethoxydiglycol, Eugenia Caryophyllus (clove) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Melia Azadirachta Extract, Panthenol, PPG-5 Ceteth-20, Propylene Glycol, Saccharide Isomerate, Salvia Sclarea (Clary) Oil, SD Alcohol 40-B/Alcohol Denat, Colloidal Sulfur, Water/Aqua, Xanthan Gum, Yeast Extract.

Reported adverse events (FAERS/openFDA)#

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