Teeth - gums

Teeth - gums
SPL v2
SPL
SPL Set ID 171b2305-155b-e490-d4f9-d2334b36b4ff
Route
ORAL
Published
Effective Date 2012-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Purpose

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


Medication Information

Purpose

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

Description

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

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

Inactive Ingredient Section

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

Indications & Usage Section

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Aconitum nap. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Kreosotum15x, Merc. viv. 15x, Myrrha 15x, Nux vom. 15x, Phosphorus 15x, Phytolacca 15x, Plantago 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysag. 15x, Chamomilla 3x, Echinacea 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Aconitum nap. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Kreosotum15x, Merc. viv. 15x, Myrrha 15x, Nux vom. 15x, Phosphorus 15x, Phytolacca 15x, Plantago 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysag. 15x, Chamomilla 3x, Echinacea 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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)