Eczema 4799l

Eczema 4799l
SPL v2
SPL
SPL Set ID 98fb65dc-6c97-3b9d-e053-2995a90ade26
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Smilax Ornata Root (20 [hp_X]) Antimony Trisulfide (11 [hp_X]) Arsenic Cation (3+) 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
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02
Description

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

Purpose

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

Medication Information

Purpose

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

Description

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

Package Label

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.

Questions Section

newtonlabs.net - Questions? 800.448.7256

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

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%.

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 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.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800.448.7256

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

Otc Purpose Section (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 INGREDIENT SECTION)

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

Indications & Usage Section (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 (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 (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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:56.559975 · Updated: 2026-03-14T23:14:59.768699