MacDee: Homeopathic Product Information

MACDEE- aconitum napellus, barium carbonate, atropa belladonna, crotalus horridus horridus venom, euphrasia stricta, gelsemium sempervirens root, hamamelis virginiana root bark/stem bark, lachesis muta venom, mercury, phosphorus, picric acid, lead, anemone pulsatilla, toxicodendron pubescens leaf, datura stramonium, theridion curassavicum, micrurus corallinus venom and gold 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 such as blurry vision, loss of night vision and trouble discerning colors.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Aconitum napellus 15x, Aurum metallicum 15x, Baryta carbonica 15x, Belladonna 15x, Crotalus horridus 15x, Euphrasia officinalis 15x, Gelsemium sempervirens 15x, Hamamelis virginiana 15x, Lachesis mutus 15x, Mercurius vivus 15x, Phosphorus 15x, Picricum acidum 15x, Plumbum metallicum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Stramonium 15x, Theridion 15x, Elaps corallinus 30x.

OTC — PURPOSE SECTION

Formulated for symptoms such as blurry vision, loss of night vision and trouble discerning colors.

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

MACDEE aconitum napellus, aurum metallicum, baryta carbonica, belladonna, crotalus horridus, euphrasia officinalis, gelsemium sempervirens, hamamelis virginiana, lachesis mutus, mercurius vivus, phosphorus, picricum acidum, plumbum metallicum, pulsatilla, rhus toxicodendron, stramonium, theridion, elaps corallinus. liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4827 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 BARIUM CARBONATE (BARIUM CATION) BARIUM CARBONATE 15 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 15 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X] in 1 mL EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 15 [hp_X] in 1 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 15 [hp_X] in 1 mL MERCURY (MERCURY) MERCURY 15 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 15 [hp_X] in 1 mL PICRIC ACID (PICRIC ACID) PICRIC ACID 15 [hp_X] in 1 mL LEAD (LEAD) LEAD 15 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL DATURA STRAMONIUM (DATURA STRAMONIUM) DATURA STRAMONIUM 15 [hp_X] in 1 mL THERIDION CURASSAVICUM (THERIDION CURASSAVICUM) THERIDION CURASSAVICUM 15 [hp_X] in 1 mL MICRURUS CORALLINUS VENOM (MICRURUS CORALLINUS VENOM) MICRURUS CORALLINUS VENOM 30 [hp_X] in 1 mL GOLD (GOLD) GOLD 15 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4827-1 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 (55714-4827)

Revised: 12/2020 Newton Laboratories, Inc.