FDA.reportPublic FDA data

Vitiligo

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:50

Label at a glance#

ProductVitiligo
Active ingredientArsenic Trioxide, Berberis Vulgaris Root Bark, Giant Puffball, Mucuna Pruriens Fruit Trichome, Echinacea, Unspecified, Hura Crepitans Sap, Centella Asiatica, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Toxicodendron Pubescens Leaf, Rumex Crispus Root, Sepia Officinalis Juice, Taraxacum Officinale, Thuja Occidentalis Leafy Twig, Urtica Urens, Iris Versicolor Root
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Berber. vulg. 10x, Bovista 10x, Dolichos 10x, Echinacea 10x, Hura brasiliensis 10x, Hydrocotyle 10x, Lycopodium 10x, Mezereum 10x, Rhus toxicodendron 10x, Rumex crisp. 10x, Sepia 10x, Taraxacum 10x, Thuja occ. 10x, Urtica ur. 10x, Echinacea 3x, Iris versicolor 3x, Rumex crisp. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

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
55714-2350-02020-01-31C16284748780-19d75b9d1-1a22-f424-e053-dadaa90a57ceVitiligo
55714-2350-12020-01-31C16284748780-19d75b9d1-1a22-f424-e053-dadaa90a57ceVitiligo
55714-2350-22020-01-31C16284748780-19d75b9d1-1a22-f424-e053-dadaa90a57ceVitiligo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2350-0Vitiligo.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2350-1Vitiligo29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2350-2Vitiligo59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2350VITILIGO (ARSENICUM ALB., BERBER. VULG., BOVISTA, DOLICHOS, ECHINACEA, HURA BRASILIENSIS, HYDROCOTYLE, LYCOPODIUM, MEZEREUM, RHUS TOXICODENDRON, RUMEX CRISP., SEPIA, TARAXACUM,THUJA OCC., URTICA UR., IRIS VERSICOLOR) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130808_cba959cf-fcc0-ed50-5703-362188d57092.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U2
Centella AsiaticaACTIVE INGREDIENT7M867G6T1U2
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Giant PuffballACTIVE INGREDIENTI6839Y031A2
Hura Crepitans SapACTIVE INGREDIENT8UHN1I06UP2
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Mucuna Pruriens Fruit TrichomeACTIVE INGREDIENT3E271BSI0C2
Rumex Crispus RootACTIVE INGREDIENT9N1RM2S62C2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3752
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF92
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U2
Centella AsiaticaACTIVE MOIETY7M867G6T1U2
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Giant PuffballACTIVE MOIETYI6839Y031A2
Hura Crepitans SapACTIVE MOIETY8UHN1I06UP2
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Mucuna Pruriens Fruit TrichomeACTIVE MOIETY3E271BSI0C2
Rumex Crispus RootACTIVE MOIETY9N1RM2S62C2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Taraxacum OfficinaleACTIVE MOIETY39981FM3752
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Urtica UrensACTIVE MOIETYIHN2NQ5OF92
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-235055714-2350-1, 55714-2350-2, 55714-2350-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Arsenic TrioxideS7V92P67HOACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Giant PuffballI6839Y031AACTIB
Mucuna Pruriens Fruit Trichome3E271BSI0CACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Hura Crepitans Sap8UHN1I06UPACTIB
Centella Asiatica7M867G6T1UACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Taraxacum Officinale39981FM375ACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 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
39a94f92-80ab-2615-2dd5-a93cad659620cba959cf-fcc0-ed50-5703-362188d570922011-03-01WarningsExact identifier
spl id: 39a94f92-80ab-2615-2dd5-a93cad659620
spl set id: cba959cf-fcc0-ed50-5703-362188d57092

Reported adverse events (FAERS/openFDA)#

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