WARTS - MOLES - SKIN TAGS - antimony trisulfide, bryonia alba root, oyster shell calcium carbonate, crude, causticum, solanum dulcamara top, graphite, lycopodium clavatum spore, mercuric sulfide, sodium carbonate, nitric acid, strychnos nux-vomica seed, toxicodendron pubescens leaf, juniperus sabina leafy twig, sepia officinalis juice, silicon dioxide, delphinium staphisagria seed, sulfur, thuja occidentalis leafy twig and taraxacum officinale 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Warts - Moles - Skin Tags Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Bryonia 15x, Calc.carb. 15x, Causticum 15x, Dulcamara 15x, Graphites 15x, Lycopodium 15x, Merc. sulph. rub. 15x, Nat. carb. 15x, Nitricum ac.15x, Nux vom. 15x, Rhus toxicodendron 15x, Sabina 15x, Sepia 15x, Silicea 15x, Staphysag. 15x, Sulphur 15x, Thuja occ. 15x, Taraxacum 3x, Thuja occ. 3x.

OTC - PURPOSE SECTION

Formulated for various types of skin conditions such as warts (including genital), moles, keloids, molluscum and skin tags.

INACTIVE INGREDIENT SECTION

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

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

WARTS - MOLES - SKIN TAGS
antimon. crud., bryonia, calc.carb., causticum, dulcamara, graphites, lycopodium, merc. sulph. rub., nat. carb., nitricum ac., nux vom., rhus toxicodendron, sabina, sepia, silicea, staphysag., sulphur, thuja occ., taraxacum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2270
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Antimony Trisulfide (Antimony Trisulfide)	Antimony Trisulfide	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude)	Oyster Shell Calcium Carbonate, Crude	15 [hp_X] in 1 mL
Causticum (Causticum)	Causticum	15 [hp_X] in 1 mL
Solanum Dulcamara Top (Solanum Dulcamara Top)	Solanum Dulcamara Top	15 [hp_X] in 1 mL
Graphite (Graphite)	Graphite	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Mercuric Sulfide (Mercuric Cation)	Mercuric Sulfide	15 [hp_X] in 1 mL
Sodium Carbonate (Carbonate Ion)	Sodium Carbonate	15 [hp_X] in 1 mL
Nitric Acid (Nitric Acid)	Nitric Acid	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Juniperus Sabina Leafy Twig (Juniperus Sabina Leafy Twig)	Juniperus Sabina Leafy Twig	15 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	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
Sulfur (Sulfur)	Sulfur	15 [hp_X] in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig)	Thuja Occidentalis Leafy Twig	15 [hp_X] in 1 mL
Taraxacum Officinale (Taraxacum Officinale)	Taraxacum Officinale	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2270-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2270-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2270-0	.5 mL 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(55714-2270), API MANUFACTURE(55714-2270)

Revised: 03/2011

Document Id: 6a543d9c-c873-cca0-b5f6-82f9422c6500

Set id: 1e3d851f-3515-9830-a8e9-ee6d5a1df7a4

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.