RoyceDerm Tea Tree Therapeutic

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)

Brand name: RoyceDerm Tea Tree Therapeutic
Generic name: SALICYLIC ACID 3%
Manufacturer: RoyceDerm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 46542754-2256-a23c-e063-6394a90a7795
SPL ID: 46542754-2257-a23c-e063-6394a90a7795
Version: 1
Effective date: 2025-12-19
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:28:46

Harmonized routes table
Harmonized routes
TOPICAL

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M032	openfda.application_number
brand name		RoyceDerm Tea Tree Therapeutic	openfda.brand_name
generic name		SALICYLIC ACID 3%	openfda.generic_name
manufacturer name		RoyceDerm LLC	openfda.manufacturer_name
ndc	package	85424-012-01	openfda.package_ndc
ndc	product	85424-012	openfda.product_ndc
ndc11	package	85424001201	derived:openfda.package_ndc
spl id		46542754-2257-a23c-e063-6394a90a7795	id
spl set id		46542754-2256-a23c-e063-6394a90a7795	set_id
unii		O414PZ4LPZ	openfda.unii

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

For external use only Do not use it on damaged or inflamed scalp. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. If condition worsens or does not improve after regular use. If children under 12 years old, and pregnant or breast-feeding. If swallowed, get medical help or contact a posion control center. Keep out of reach of Children.

Reported adverse events (FAERS/openFDA)#

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