FDA.reportPublic FDA data

Miracle Plus Homeopathic

Manufacturer
Concept Laboratories, Inc. | Filltech USA, LLC
Effective date
2014-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:09

Label at a glance#

ProductMiracle Plus Homeopathic Skin Tag Remover
Active ingredientTHUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

Apply 3 times daily to affected area. Skin tags will dry and flake away over several week period. Some individuals may be sensitive to essential oil. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Storage and handling

Do not use if cap tamper evident seal is broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Thuja Occidentalis 6X (HPUS)

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Cutaneous Skin Tags Relief

Use

INDICATIONS & USAGE SECTION

Symptomatic treatment of Skin Tags.

Warnings

WARNINGS SECTION

For external use only. Avoid using near the eyes or mouth.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Other Information

STORAGE AND HANDLING SECTION

Do not use if cap tamper evident seal is broken.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 3 times daily to affected area. Skin tags will dry and flake away over several week period. Some individuals may be sensitive to essential oil. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Other ingredients

INACTIVE INGREDIENT SECTION

Cedar Leaf Oil, Melaleuca Alternifollia Leaf Oil, Ricinus Communis Seed Oil.

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MIRACLE
PLUS®

HOMEOPATHIC

Skin Tag
Remover

0.34 FL OZ (10 mL)

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-151-212020-01-31C16284748780-19d75b9d0-654a-f424-e053-dadaa90a57ceMiracle Plus ® Homeopathic Skin Tag Remover

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-151-21Miracle Plus Homeopathic Skin Tag Remover10 mL in 1 BOTTLE, WITH APPLICATORLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-151MIRACLE PLUS HOMEOPATHIC SKIN TAG REMOVER (THUJA OCCIDENTALIS LEAFY TWIG) LIQUID [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20141111_791fe48e-60a4-4112-a3fe-ea13b7119ce4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLG1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1

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
64058-15164058-151-21

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
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
CEDAR LEAF OILBJ169U4NLGIACT
TEA TREE OILVIF565UC2GIACT
CASTOR OILD5340Y2I9GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates

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
5a7ef586-d0ee-478f-8d69-7c8ff0b2cc23791fe48e-60a4-4112-a3fe-ea13b7119ce42014-11-05WarningsExact identifier
spl id: 5a7ef586-d0ee-478f-8d69-7c8ff0b2cc23
spl set id: 791fe48e-60a4-4112-a3fe-ea13b7119ce4

Reported adverse events (FAERS/openFDA)#

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