NECK BACK SCIATIC REMEDY- phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum lotion

Neck Back Sciatic Remedy by

Drug Labeling and Warnings

Neck Back Sciatic Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients

HPUS** Active Ingredients: Phytolacca Decandra 1X (muscle pain), Gnaphalium Polycephalum 3X (intense pain/numbness along nerve), Hypericum Perforatum 3X (lower back pain), Colocynthis 6X (nerve pain), Gelsemium Sempervirens 6X (burning along nerve), Guaiacum 6X (neck pain), Ledum Palustre 6X (back pain), Conium Maculatum 30X (back pain).

**"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses*

Indications*: May temporarily relieve minor symptoms of back pain and neck discomfort and sharp pain along the sciatic nerve, lower back, and down the back of legs.

*As per various homeopathic materia medicas. These indications have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. For external use only. Avoid using near eyes or mouth. If swallowed, get medical help or contact a Poison Control Center immediately. Some individuals may be sensitive to ingredients, if irritation or reaction occurs, discontinue use. Intended to complement, not replace, standard medical care.

Directions

Directions: Apply at least 3 times daily over the affected area. Children under 12 years of age: consult a doctor before use.

OTHER SAFETY INFORMATION

Paraben free. No petroleum. No animal testing. No artivicial colors or fragrances.

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients

Purified Water, Whey Protein Concentrate (milk); Benzyl Alcohol & Ethylhexylglycerin & Tocopherals, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Arnica Montana (Arnica) Flower Extract, Symphytum Officinale (Comfrey) Leaf Extract, Piscidia Piscipula (Jamaica Dogwood) Bark Extract, Phytolacca Americana (Poke) Root Extract, Hypericum Perforatum (St. John's Wort) Aerial Parts Extract, Salix Alba (White Willow) Bark Extract, Achillea Millefolium (Yarrow) Flower Extract, Lavandula Angustifolia (Lanvender) Buds Extract, Sodium Hydroxide (solution), Edetate Disodium (EDTA), Ascorbic Acid (Vitamin C powder).

KEEP OUT OF REACH OF CHILDREN

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

PURPOSE

Homeopathic Lotion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NECK BACK SCIATIC REMEDY 
phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	1 [hp_X]  in 113 g
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	3 [hp_X]  in 113 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X]  in 113 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30 [hp_X]  in 113 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 113 g
CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6)	CITRULLUS COLOCYNTHIS FRUIT	6 [hp_X]  in 113 g
GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6)	GUAIACUM OFFICINALE RESIN	6 [hp_X]  in 113 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 113 g

Inactive Ingredients
Ingredient Name	Strength
PISCIDIA PISCIPULA WHOLE (UNII: ERY1DHL39V)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
WHEY (UNII: 8617Z5FMF6)
WATER (UNII: 059QF0KO0R)
SALIX ALBA BARK (UNII: 205MXS71H7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-215-04	113 g in 1 JAR; Type 0: Not a Combination Product	12/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/11/2017

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(68703-215)