NDC | 55714-2283-0, 55714-2283-1, 55714-2283-2 |
Set ID | 8cbfb995-14e0-e61e-36a5-7865f8cc166f |
Category | HUMAN OTC DRUG LABEL |
Packager | Newton Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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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 pelletProduct 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)