TEETH - GUMS- aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus, crotalus horridus, gelsemium, hepar sulph. calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, silicea, staphysag., echinacea pellet

Teeth - Gums by

Drug Labeling and Warnings

Teeth - Gums by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet 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 - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

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.  

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.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

TEETH - GUMS  
aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus, crotalus horridus, gelsemium, hepar sulph. calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, silicea, staphysag., echinacea pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2283
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	15 [hp_X]  in 1 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW)	Arnica Montana	15 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	15 [hp_X]  in 1 g
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y)	Baptisia Tinctoria	15 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	15 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ)	Calendula Officinalis Flowering Top	15 [hp_X]  in 1 g
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	15 [hp_X]  in 1 g
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN)	Chelidonium Majus	15 [hp_X]  in 1 g
Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956)	Crotalus Horridus Horridus Venom	15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	15 [hp_X]  in 1 g
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q)	Calcium Sulfide	15 [hp_X]  in 1 g
Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73)	Wood Creosote	15 [hp_X]  in 1 g
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	15 [hp_X]  in 1 g
Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L)	Myrrh	15 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	15 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W)	Phosphorus	15 [hp_X]  in 1 g
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	15 [hp_X]  in 1 g
Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U)	Plantago Major	15 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A)	Toxicodendron Pubescens Leaf	15 [hp_X]  in 1 g
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4)	Silicon Dioxide	15 [hp_X]  in 1 g
Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV)	Delphinium Staphisagria Seed	15 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-2283-1	28.35 g in 1 BOTTLE, GLASS
2	NDC: 55714-2283-2	56.7 g in 1 BOTTLE, GLASS
3	NDC: 55714-2283-0	7.08 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2283)