Label: NECK BACK SCIATIC REMEDY- phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum lotion
- NDC Code(s): 68703-215-04
- Packager: Silver Star Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 4, 2023
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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.
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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.
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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
- OTHER SAFETY INFORMATION
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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
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NECK BACK SCIATIC REMEDY
phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum lotionProduct 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)
