ECZEMA - SKIN CARE - antimony trisulfide, arsenic trioxide, berberis vulgaris root bark, giant puffball, bryonia alba root, lytta vesicatoria, chelidonium majus, croton tiglium seed, solanum dulcamara top, graphite, calcium sulfide, lycopodium clavatum spore, daphne mezereum bark, strychnos nux-vomica seed, kerosene, pulex irritans, pulsatilla vulgaris, toxicodendron pubescens leaf, smilax regelii root, sepia officinalis juice, sulfur iodide, echinacea, unspecified, rumex crispus root, taraxacum officinale and urtica urens 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

Eczema - Skin Care Formulated for symptoms such as inflammation, itching, pain and sensitivity associated with eczema, psoriasis, sunburn, rashes and other skin conditions.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed 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, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sepia 15x, Sulphur iod. 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms such as inflammation, itching, pain and sensitivity associated with eczema, psoriasis, sunburn, rashes and other skin conditions.

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

ECZEMA - SKIN CARE
antimon. crud., arsenicum alb., berber. vulg., bovista, bryonia, cantharis, chelidonium majus, croton, dulcamara, graphites, hepar sulph. calc., lycopodium, mezereum, nux vom., petroleum, pulex irritans, pulsatilla, rhus toxicodendron, sarsaparilla, sepia, sulphur iod., echinacea, rumex crisp., taraxacum, urtica ur. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2232
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
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark)	Berberis Vulgaris Root Bark	15 [hp_X] in 1 mL
Giant Puffball (Giant Puffball)	Giant Puffball	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria)	Lytta Vesicatoria	15 [hp_X] in 1 mL
Chelidonium Majus (Chelidonium Majus)	Chelidonium Majus	15 [hp_X] in 1 mL
Croton Tiglium Seed (Croton Tiglium Seed)	Croton Tiglium Seed	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
Calcium Sulfide (Calcium Sulfide)	Calcium Sulfide	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark)	Daphne Mezereum Bark	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Kerosene (Kerosene)	Kerosene	15 [hp_X] in 1 mL
Pulex Irritans (Pulex Irritans)	Pulex Irritans	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Smilax Regelii Root (Smilax Regelii Root)	Smilax Regelii Root	15 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	15 [hp_X] in 1 mL
Sulfur Iodide (Sulfur Iodide)	Sulfur Iodide	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Rumex Crispus Root (Rumex Crispus Root)	Rumex Crispus Root	3 [hp_X] in 1 mL
Taraxacum Officinale (Taraxacum Officinale)	Taraxacum Officinale	3 [hp_X] in 1 mL
Urtica Urens (Urtica Urens)	Urtica Urens	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2232-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2232-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2232-0	.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(55714-2232), API MANUFACTURE(55714-2232)

Revised: 03/2011

Document Id: 2570d8c7-d2ed-98a6-574b-045a99b0c864

Set id: 21c29a08-f2eb-d97d-93c8-5edc6bf322da

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.