FDA.reportPublic FDA data

Threefold Balance

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:29:43

Label at a glance#

ProductThreefold Balance
Active ingredientOLIBANUM, MYRRH, GOLD
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Myrrha (Myrrh resin) 7X, Olibanum (Rubber resin) 7X, Aurum met. (Metallic gold) 10X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Temporarily relieves symptoms of stress and environmental sensitivity.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Threefold Balance PelletsThreefold Balance Pellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-9388-2Threefold Balance1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-9388THREEFOLD BALANCE PELLET [URIEL PHARMACY, INC.]11 package rows20241220_298d5510-8b45-51b7-e063-6294a90a9ac7.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-938848951-9388-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIBANUMR9XLF1R1WMACTIB
SUCROSEC151H8M554IACT
MYRRHJC71GJ1F3LACTIB
GOLD79Y1949PYOACTIB

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
298d51b3-090e-1502-e063-6294a90ad24c298d5510-8b45-51b7-e063-6294a90a9ac72024-12-17WarningsExact identifier
spl id: 298d51b3-090e-1502-e063-6294a90ad24c
spl set id: 298d5510-8b45-51b7-e063-6294a90a9ac7

Reported adverse events (FAERS/openFDA)#

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