Teeth 2528l

Teeth 2528l
SPL v2
SPL
SPL Set ID 9d27b1e4-a966-5495-e053-2a95a90a965b
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Delphinium Staphisagria Seed (15 [hp_X]) Echinacea, Unspecified (6 [hp_X]) Arsenic Cation (3+) Baptisia Tinctoria Root Atropa Belladonna Bryonia Alba Root Calendula Officinalis Flowering Top Matricaria Chamomilla Chelidonium Majus Crotalus Horridus Horridus Venom Aconitum Napellus Calcium Sulfide Wood Creosote Mercury Myrrh Strychnos Nux-vomica Seed Phosphorus Phytolacca Americana Root Plantago Major Toxicodendron Pubescens Leaf Silicon Dioxide Arnica Montana Gelsemium Sempervirens Root
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Purpose

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.


Medication Information

Purpose

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Description

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.

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 mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Chamomilla 6x, Echinacea 6x, Aconitum napellus 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calendula officinalis 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Kreosotum 15x, Mercurius vivus 15x, Myrrha 15x, Nux vomica 15x, Phosphorus 15x, Phytolacca decandra 15x, Plantago major 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysagria 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 mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Chamomilla 6x, Echinacea 6x, Aconitum napellus 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calendula officinalis 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Kreosotum 15x, Mercurius vivus 15x, Myrrha 15x, Nux vomica 15x, Phosphorus 15x, Phytolacca decandra 15x, Plantago major 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysagria 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)