Injury 4795l

Injury 4795l
SPL v2
SPL
SPL Set ID 995da3c4-d236-f212-e053-2a95a90a402f
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Goldenseal (11 [hp_X]) Aconitum Napellus (20 [hp_X]) Arnica Montana Bellis Perennis Calendula Officinalis Flowering Top Echinacea, Unspecified Gelsemium Sempervirens Root Hamamelis Virginiana Root Bark/stem Bark Hypericum Perforatum Rhododendron Tomentosum Leafy Twig Phosphorus Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Delphinium Staphisagria Seed Comfrey Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

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

Purpose

Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising and inflammation.


Medication Information

Purpose

Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising and inflammation.

Description

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

Questions

newtonlabs.net – Questions? 800.448.7256

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

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.

Otc Purpose Section

Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising 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 trauma or medical procedures such as pain, emotional upset, bruising and inflammation.

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, Hydrastis 6x, Hypericum 6x, Symphytum 6x, Aconitum nap. 15x, Arnica 15x, Bellis 15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phos. 15x, Rhus tox. 15x, Ruta 15x, Staphysag. 15x, Symphytum 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

Questions (QUESTIONS)

newtonlabs.net – Questions? 800.448.7256

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

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.

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with trauma or medical procedures such as pain, emotional upset, bruising 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 trauma or medical procedures such as pain, emotional upset, bruising and inflammation.

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, Hydrastis 6x, Hypericum 6x, Symphytum 6x, Aconitum nap. 15x, Arnica 15x, Bellis 15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phos. 15x, Rhus tox. 15x, Ruta 15x, Staphysag. 15x, Symphytum 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)