FDA.reportPublic FDA data

Kali Sulf. Bath Essence

Manufacturer
Uriel Pharmacy Inc.
Effective date
2014-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:56

Label at a glance#

ProductKali Sulf. Bath Essence
Active ingredientPOTASSIUM SULFIDE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY. SHAKE WELL BEFORE USE.

DOSAGE & ADMINISTRATION SECTION

For compresses: Use 2 teaspoons per cup of lukewarm water. For full bath: Use 2-3 tablespoons.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Kalium sulfuratum 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Distilled water

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: FOR EXTERNAL USE ONLY. 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 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-6005-62020-01-31C16284748780-19d75b9d0-47b0-f424-e053-dadaa90a57ceKali Sulf. Bath Essence

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-6005-6Kali Sulf. Bath Essence125 mL in 1 BOTTLE, GLASSLIQUID1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-6005KALI SULF. BATH ESSENCE LIQUID [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20140821_efeb9f62-f328-4d77-8cb3-e4c96fab621e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM SULFIDEACTIVE INGREDIENT31R0R7HD0N1
SULFATE IONACTIVE MOIETY7IS9N8KPMG1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-600548951-6005-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SULFIDE31R0R7HD0NACTIB
WATER059QF0KO0RIACT

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
e3cafac5-b3cb-4454-8237-c0af3d9bd2e3efeb9f62-f328-4d77-8cb3-e4c96fab621e2014-08-06WarningsExact identifier
spl id: e3cafac5-b3cb-4454-8237-c0af3d9bd2e3
spl set id: efeb9f62-f328-4d77-8cb3-e4c96fab621e

Reported adverse events (FAERS/openFDA)#

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