SCIATISOOTHE- aconitum napellus, berberis vulgaris, chamomilla, colocynthis, magnesia phosphorica, rhus tox spray

SciatiSoothe by

Drug Labeling and Warnings

SciatiSoothe by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HPUS Active Ingredients

Each dose contains equal parts of: Aconitum napellus 6C, Berberis vulgaris 3X, Chamomilla 2X, Colocynthis 30C, Magnesia phosphorica 8X, Rhus tox 30C.

Uses

*Homeopathic medicine for the temporary relief of sciatic pain and pressure. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children.

Directions

Before initial use, depress pump 4-5 times or until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily, as needed, or until symptoms improve. Adults: Take 3 sprays. Children 2-12: Take 2 sprays.

Other Information

Contains no artificial flavors or colors. No gluten added. Suitable for vegetarians. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Tamper resistant for your protection. Use only if safety seal is intact.

INACTIVE INGREDIENT

Citric acid, potassium sorbate, purified water.

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Reduces occasional pain, pressure & inflammation from sciatica

INGREDIENTS AND APPEARANCE

SCIATISOOTHE 
aconitum napellus, berberis vulgaris, chamomilla, colocynthis, magnesia phosphorica, rhus tox spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-203
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_C]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X]  in 59 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_C]  in 59 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X]  in 59 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-203-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/15/2016

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-203) , api manufacture(68703-203)