Label: ORAL CARE - GINGIVITIS- 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, slicea, staphysag., echinacea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4440-1, 55714-4440-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 1, 2011
If you are a consumer or patient please visit this version.
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Aconitum nap. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Calendula 20x, Chamomilla 20x, Chelidonium majus 20x, Crotalus horridus 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Kreosotum 20x, Merc. viv. 20x, Myrrha 20x, Nux vom. 20x, Phosphorus 20x, Phytolacca 20x, Plantago 20x, Rhus toxicodendron 20x, Silicea 20x, Staphysag. 20x, Chamomilla 8x, Echinacea 8x, Chamomilla 3x, Echinacea 3x.
- 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
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL.
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INGREDIENTS AND APPEARANCE
ORAL CARE - GINGIVITIS
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, slicea, staphysag., echinacea liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4440 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 20 [hp_X] in 1 mL Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 20 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 20 [hp_X] in 1 mL Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root 20 [hp_X] in 1 mL Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 20 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 mL Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top 20 [hp_X] in 1 mL Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 20 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 20 [hp_X] in 1 mL Crotalus Horridus Horridus Venom (UNII: YHA2XLJ956) (Crotalus Horridus Horridus Venom - UNII:YHA2XLJ956) Crotalus Horridus Horridus Venom 20 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 mL Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 20 [hp_X] in 1 mL Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote 20 [hp_X] in 1 mL Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 20 [hp_X] in 1 mL Myrrh (UNII: JC71GJ1F3L) (Myrrh - UNII:JC71GJ1F3L) Myrrh 20 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 20 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 20 [hp_X] in 1 mL Plantago Major (UNII: W2469WNO6U) (Plantago Major - UNII:W2469WNO6U) Plantago Major 20 [hp_X] in 1 mL Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 20 [hp_X] in 1 mL Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 20 [hp_X] in 1 mL Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed 20 [hp_X] in 1 mL Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 8 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4440-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4440-2 59.14 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4440)
