Oral Care-Gingivitis: Homeopathic Product Information

ORAL CARE-GINGIVITIS- aconitum napellus, arnica montana, arsenic trioxide, baptisia tinctoria root, atropa belladonna, bryonia alba root, calendula officinalis flowering top, matricaria chamomilla, 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 and echinacea, unspecified liquid
Newton Laboratories, Inc.

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.

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with periodontal conditions such as gingivitis, halitosis, teeth pain 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.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, 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.

OTC — PURPOSE SECTION

Formulated for symptoms associated peridontal conditions such as gingivitis, halitosis, teeth pain and gum sensitivity.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 — Conyers, GA 30013

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.

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.

PACKAGE 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, silicea, staphysag., echinacea liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4789 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 15 [hp_X] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL BAPTISIA TINCTORIA ROOT (BAPTISIA TINCTORIA ROOT) BAPTISIA TINCTORIA ROOT 15 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 15 [hp_X] in 1 mL CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 15 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 15 [hp_X] in 1 mL WOOD CREOSOTE (WOOD CREOSOTE) WOOD CREOSOTE 15 [hp_X] in 1 mL MERCURY (MERCURY) MERCURY 15 [hp_X] in 1 mL MYRRH (MYRRH) MYRRH 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 15 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 15 [hp_X] in 1 mL PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 15 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (DELPHINIUM STAPHISAGRIA SEED) DELPHINIUM STAPHISAGRIA SEED 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4789-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019

Labeler — Newton Laboratories, Inc. (788793610)

Registrant — Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Operations
Newton Laboratories, Inc.		788793610	manufacture (55714-4789)

Revised: 12/2020 Newton Laboratories, Inc.