FDA.reportPublic FDA data

Eczema Skin Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:35

Label at a glance#

ProductEczema Skin Care
Active ingredientAntimony Trisulfide, Arsenic Trioxide, Berberis Vulgaris Root Bark, Giant Puffball, Bryonia Alba Root, Lytta Vesicatoria, Chelidonium Majus, Croton Tiglium Seed, Solanum Dulcamara Top, Graphite, Calcium Sulfide, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Strychnos Nux-vomica Seed, Kerosene, Pulex Irritans, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Smilax Regelii Root, Sepia Officinalis Juice, Sulfur Iodide, Echinacea Angustifolia, Rumex Crispus Root, Taraxacum Officinale, Urtica Urens
Label structure9 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

ECZEMA~SKIN CARE    Formulated for symptoms associated with seborrhea, eczema, psoriasis, cellulitis, dermatitis, lichen planus and other skin-related conditions.        

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. 

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 20x, Arsenicum alb. 20x, Berber. vulg. 20x, Bovista 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Croton 20x, Dulcamara 20x, Graphites 20x, Hepar sulph. calc. 20x, Lycopodium 20x, Mezereum 20x, Nux vom. 20x, Petroleum 20x, Pulex irritans 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sarsaparilla 20x, Sepia 20x, Sulphur iod. 20x, Echinacea 8x, Rumex crisp. 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.                   

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 Image
Package Image

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
55714-4402-12020-01-31C16284748780-19d75b9d1-0837-f424-e053-dadaa90a57ceEczema Skin Care
55714-4402-22020-01-31C16284748780-19d75b9d1-0837-f424-e053-dadaa90a57ceEczema Skin Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4402-1Eczema Skin Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-4402-2Eczema Skin Care59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4402ECZEMA SKIN CARE (ANTIMON. CRUD., ARSENICUM ALB., BERBER. VULG., BOVISTA , BRYONIA , CANTHARIS , CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HEPAR SULPH. CALC., LYCOPODIUM MEZEREUM, NUX VOM, PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR IOD, ECHINACEA, RUMEX CRISP., TARAXACUM , URTICA UR., ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20120327_5f79a7a8-6a81-a7fb-9640-8dfb80152b5c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Croton Tiglium SeedACTIVE INGREDIENT0HK2GZK66E1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Echinacea AngustifoliaACTIVE INGREDIENTVB06AV5US81
Giant PuffballACTIVE INGREDIENTI6839Y031A1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
KeroseneACTIVE INGREDIENT1C89KKC04E1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Pulex IrritansACTIVE INGREDIENTL63DD62R8R1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Rumex Crispus RootACTIVE INGREDIENT9N1RM2S62C1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Smilax Regelii RootACTIVE INGREDIENT2H1576D5WG1
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Sulfur IodideACTIVE INGREDIENTL6L8KA2AA01
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3751
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF91
AntimonyACTIVE MOIETY9IT35J3UV31
Arsenic TrioxideACTIVE MOIETYS7V92P67HO1
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CalciumACTIVE MOIETYSY7Q814VUP1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Croton Tiglium SeedACTIVE MOIETY0HK2GZK66E1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Echinacea AngustifoliaACTIVE MOIETYVB06AV5US81
Giant PuffballACTIVE MOIETYI6839Y031A1
GraphiteACTIVE MOIETY4QQN74LH4O1
KeroseneACTIVE MOIETY1C89KKC04E1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Pulex IrritansACTIVE MOIETYL63DD62R8R1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Rumex Crispus RootACTIVE MOIETY9N1RM2S62C1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Smilax Regelii RootACTIVE MOIETY2H1576D5WG1
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Sulfur IodideACTIVE MOIETYL6L8KA2AA01
Taraxacum OfficinaleACTIVE MOIETY39981FM3751
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Urtica UrensACTIVE MOIETYIHN2NQ5OF91

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-440255714-4402-1, 55714-4402-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
Antimony TrisulfideF79059A38UACTIB
Arsenic TrioxideS7V92P67HOACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Giant PuffballI6839Y031AACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Chelidonium Majus7E889U5RNNACTIB
Croton Tiglium Seed0HK2GZK66EACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Calcium Sulfide1MBW07J51QACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Kerosene1C89KKC04EACTIB
Pulex IrritansL63DD62R8RACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Smilax Regelii Root2H1576D5WGACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Sulfur IodideL6L8KA2AA0ACTIB
Echinacea AngustifoliaVB06AV5US8ACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Taraxacum Officinale39981FM375ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Echinacea AngustifoliaVB06AV5US8ACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Taraxacum Officinale39981FM375ACTIB
Urtica UrensIHN2NQ5OF9ACTIB

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
3cbecb6e-2002-8de8-bee3-c612623eb03c5f79a7a8-6a81-a7fb-9640-8dfb80152b5c2011-06-01WarningsExact identifier
spl id: 3cbecb6e-2002-8de8-bee3-c612623eb03c
spl set id: 5f79a7a8-6a81-a7fb-9640-8dfb80152b5c

Reported adverse events (FAERS/openFDA)#

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