Eczema - Skin Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:43

Label at a glance#

ProductEczema - Skin Care
Active ingredientSMILAX ORNATA ROOT, ANTIMONY TRISULFIDE, ARSENIC TRIOXIDE, BERBERIS VULGARIS ROOT BARK, LYCOPERDON UTRIFORME FRUITING BODY, 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, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, SULFUR IODIDE, ECHINACEA, UNSPECIFIED, RUMEX CRISPUS ROOT, TARAXACUM OFFICINALE, URTICA URENS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with eczema, psoriasis, sunburn, rashes and other skin conditions such as itching, pain, sensitivity and inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions: ges 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Equal parts of Echinacea 11x, Rumex crispus 11x, Taraxacum officinale 11x, Urtica urens 11x, Antimonium crudum 20x, Arsenicum album 20x, Berberis vulgaris 20x, Bovista 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Croton tiglium 20x, Dulcamara 20x, Graphites 20x, Hepar sulphuris calcareum 20x, Lycopodium clavatum 20x, Mezereum 20x, Nux vomica 20x, Petroleum 20x, Pulex irritans 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sarsaparilla 20x, Sepia 20x, Sulphur iodatum 20x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with eczema, psoriasis, sunburn, rashes and other skin conditions such as itching, pain, sensitivity and inflammation.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4799-1Eczema - Skin Care30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4799ECZEMA - 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.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201203_98fb65dc-6c97-3b9d-e053-2995a90ade26.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-479955714-4799-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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
Eczema - Skin CareANTIMON. 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.Newton Laboratories, Inc.98fb65dc-6c97-3b9d-e053-2995a90ade262020-12-02WarningsExact identifier
ndc (package): 55714-4799-1
ndc (product): 55714-4799
ndc11 (package): 55714479901
spl id: b583fbea-e1f6-6bed-e053-2995a90a86fe
spl set id: 98fb65dc-6c97-3b9d-e053-2995a90ade26

Reported adverse events (FAERS/openFDA)#

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