PRODUCT NAME & INDICATIONS SECTION

Sciatica~Back Care Formulated for associated symptoms such as inflammation, sharp or throbbing pain, paresthesia and discomfort.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Aconitum nap. 20x, Ammonium benzoicum 20x, Arsenicum alb. 20x, Benzoicum acidum 20x, Bryonia 20x, Causticum 20x, Cinchona 20x, Colchicum 20x, Gnaphalium polycephalum 20x, Iris versicolor 20x, Kali iod. 20x, Ledum 20x, Lithium carb. 20x, Nux vom. 20x, Phytolacca 20x, Rhus toxicodendron 20x, Ruta 20x, Sambucus nig. 20x, Strychninum 20x, Hypericum 8x, Urtica ur. 8x, Hypericum 3x, Urtica ur. 3x.

PURPOSE SECTION

Formulated for associated symptoms such as inflammation, sharp or throbbing pain, paresthesia and discomfort.

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

SCIATICA BACK
aconitum nap., ammonium benzoicum, arsenicum alb., benzoicum acidum, bryonia, causticum, cinchona, colchicum, gnaphalium polycephalum, iris versicolor, kali iod., ledum, lithium carb., nux vom., phytolacca, rhus toxicodendron, ruta, sambucus nig., strychninum, hypericum, urtica ur., hypericum, urtica ur. liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:55714-4480
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	20 [hp_X] in 1 mL
Ammonium Benzoate (UNII: AC80WD7GPF) (Ammonium Benzoate - UNII:AC80WD7GPF)	Ammonium Benzoate	20 [hp_X] in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	20 [hp_X] in 1 mL
Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM)	Benzoic Acid	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
Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU)	Causticum	20 [hp_X] in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB)	Cinchona Officinalis Bark	20 [hp_X] in 1 mL
Pseudognaphalium Obtusifolium (UNII: 36XQ854NWW) (Pseudognaphalium Obtusifolium - UNII:36XQ854NWW)	Pseudognaphalium Obtusifolium	20 [hp_X] in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC)	Iris Versicolor Root	20 [hp_X] in 1 mL
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q)	Potassium Iodide	20 [hp_X] in 1 mL
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P)	Ledum Palustre Twig	20 [hp_X] in 1 mL
Lithium Carbonate (UNII: 2BMD2GNA4V) (Lithium Cation - UNII:8H8Z5UER66)	Lithium Carbonate	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
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	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
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S)	Ruta Graveolens Flowering Top	20 [hp_X] in 1 mL
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U)	Sambucus Nigra Flowering Top	20 [hp_X] in 1 mL
Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J)	Strychnine	20 [hp_X] in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	8 [hp_X] in 1 mL
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9)	Urtica Urens	8 [hp_X] in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	3 [hp_X] in 1 mL
Urtica Urens (UNII: IHN2NQ5OF9) (Urtica Urens - UNII:IHN2NQ5OF9)	Urtica Urens	3 [hp_X] in 1 mL
Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6)	Colchicum Autumnale Bulb	20 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4480-1	29.57 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4480) , API MANUFACTURE(55714-4480)

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