Rashes 4761l

Rashes 4761l
SPL v3
SPL
SPL Set ID 9988637d-d023-399e-e053-2a95a90abca6
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Smilax Ornata Root (15 [hp_X]) Antimony Trisulfide (6 [hp_X]) Apis Mellifera 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 Histamine Lycopodium Clavatum Spore Daphne Mezereum Bark Strychnos Nux-vomica Seed Kerosene Pulex Irritans Anemone Pulsatilla Toxicodendron Pubescens Leaf Sulfur Echinacea, Unspecified Urtica Urens Rumex Crispus Root Taraxacum Officinale
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for associated symptom such as burning, itching, redness, swelling and discomfort.

Purpose

Formulated for associated symptoms such as burning, itching, redness, swelling and discomfort.


Medication Information

Purpose

Formulated for associated symptoms such as burning, itching, redness, swelling and discomfort.

Description

Formulated for associated symptom such as burning, itching, redness, swelling and discomfort.

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 associated symptoms such as burning, itching, redness, swelling and discomfort.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for associated symptom such as burning, itching, redness, swelling and discomfort.

Dosage & Administration Section

Directions: Ages 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

Equal parts of Echinacea 6x, Rumex crisp. 6x, Taraxacum 6x, Urtica ur.6x. Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x.

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 associated symptoms such as burning, itching, redness, swelling and discomfort.

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 associated symptom such as burning, itching, redness, swelling and discomfort.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 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)

Equal parts of Echinacea 6x, Rumex crisp. 6x, Taraxacum 6x, Urtica ur.6x. Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x.

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)