ARTHRIRELIEF- arnica montana, bryonia, dulcamara spray

ArthriRelief by

Drug Labeling and Warnings

ArthriRelief by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Vitality Works. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS* Active Ingredients

HPUS* Active ingredients - Equal volumes of each ingredient as follows:

Arnica montana (3X), Bryonia (6C), Dulcamara (6C).

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

Uses+

Uses+: For symptomatic treatment of aching, painful joints, stiffness and inflammation.

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

Warnings

Warnings: If symptoms persist or worsen, discontinue use immediately and consult a healthcare professional.

If pregnant or breast-feeding, ask a healthcare 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 essential oils. If irritation or reaction occurs, discontinue use.

Directions

Directions:

Shake well before using.

Spray lightly onto entire affected area.

Gently massage around joint.

Repeat 2-3 times daily as needed.

Adults and children over 12 years of age.

OTHER SAFETY INFORMATION

Other information:

Intended to complement, not replace, standard medical care.

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

Inactive ingredients

Inactive ingredients: Celery essential oil, coriander essential oil, ginger essential oil, grapeseed oil.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

HPUS* Active ingredients Purpose+

Equal volumes of each ingredient as follows:

Arnica montana (3X)......................................Stiffness, swelling

Bryonia (6C)...................................................Painful joints

Dulcamara (6C).............................................Stiffness

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTHRIRELIEF 
arnica montana, bryonia, dulcamara spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_C]  in 59 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 59 mL
SOLANUM DULCAMARA FLOWER (UNII: W6J1279A6K) (SOLANUM DULCAMARA FLOWER - UNII:W6J1279A6K)	SOLANUM DULCAMARA FLOWER	6 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CELERY SEED OIL (UNII: 8MBL58728K)
GINGER OIL (UNII: SAS9Z1SVUK)
CORIANDER OIL (UNII: 7626GC95E5)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-220-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/14/2019

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works		137752817	manufacture(68703-220) , api manufacture(68703-220)