FDA.reportPublic FDA data

Rhus tox. 10%

Manufacturer
Uriel Pharmacy Inc.
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:03

Label at a glance#

ProductRhus tox. 10%
Active ingredientTOXICODENDRON PUBESCENS LEAF
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Rhus tox. (Sumac) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic olive oil, Lanolin, Beeswax, Lanolin alcohol, Sorbic acid, Grapefruit seed extract

OTC - PURPOSE SECTION

Use: Temporary relief of rash.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: FOR EXTERNAL USE ONLY.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.urielpharmacy.com

Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rhus tox 10%Rhus tox 10%

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8369-5Rhus tox. 10%60 g in 1 TUBEOINTMENT601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8369RHUS TOX. 10% OINTMENT [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20201224_b710f4e6-3265-5353-e053-2995a90ad567.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-836948951-8369-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CITRUS PARADISI SEED12F08874Y7IACT
SORBIC ACIDX045WJ989BIACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
LANOLIN ALCOHOLS884C3FA9HEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b710f4e6-3266-5353-e053-2995a90ad567b710f4e6-3265-5353-e053-2995a90ad5672020-12-22WarningsExact identifier
spl id: b710f4e6-3266-5353-e053-2995a90ad567
spl set id: b710f4e6-3265-5353-e053-2995a90ad567

Reported adverse events (FAERS/openFDA)#

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