Well-Ex

Manufacturer
Silver Star Brands | OHM Pharma
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:17

Label at a glance#

ProductWell-Ex
Active ingredientGRAPHITE, CALCIUM SULFIDE, ARSENIC TRIOXIDE, RADIUM BROMIDE, VIOLA TRICOLOR
Label structure10 sections

Indications and uses

Uses*: Soothes transient itching and weeping of skin during an eczema 'flare up'. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage and administration

Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. Use 3 times daily, 30 minutes before food, until symptoms subside. Adults & children 13+: 2 tablets. Childeren 2-12: 1 tablet.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volumes of each ingredient: Arsenicum alb 6C, Graphites 6C, Hepar sulph calc 6C, Radium brom 30C, Viola tric 6C.

The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Soothes transient itching and weeping of skin during an eczema 'flare up'.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of oversdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. Use 3 times daily, 30 minutes before food, until symptoms subside. Adults & children 13+: 2 tablets. Childeren 2-12: 1 tablet.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Soothes symptoms of transient skin flare-ups in children with eczema or atopic dermatitis.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well-ExWell-Ex

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-318-302023-03-06C16284748780-1ba0f9c33-24e5-a910-e053-dadaa90a0b85NativeRemedies® Well-Ex™
68703-318-302021-01-29C16284748780-1ba0f9c33-24e5-a910-e053-dadaa90a0b85NativeRemedies® Well-Ex™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-318-30Well-Ex180 in 1 BOTTLE, GLASSTABLET1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-318WELL-EX (ARSENICUM ALB, GRAPHITES, HEPAR SULPH CALC, RADIUM BROM, VIOLA TRIC) TABLET [SILVER STAR BRANDS]3Current NDC, Legacy NDC, 1 package rows20241206_81f617eb-7be0-ae44-e053-2991aa0ae196.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-31868703-318-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
Well-ExARSENICUM ALB, GRAPHITES, HEPAR SULPH CALC, RADIUM BROM, VIOLA TRICSilver Star Brands81f617eb-7be0-ae44-e053-2991aa0ae1962024-12-03WarningsExact identifier
ndc (package): 68703-318-30
ndc (product): 68703-318
ndc11 (package): 68703031830
spl id: 2868c35d-f750-32cc-e063-6394a90a72dd
spl set id: 81f617eb-7be0-ae44-e053-2991aa0ae196

Reported adverse events (FAERS/openFDA)#

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