ARNICA POWER- arnica montana liquid

Arnica Power by

Drug Labeling and Warnings

Arnica Power by is a Homeopathic medication manufactured, distributed, or labeled by Eight and Company L.L.C, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Arnica montana 3X, 4X, 6X

WARNINGS

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions: Adults and children over 12: 2 sprays under the tongue 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed.

Children Under 12: consult a healthcare professional.

PURPOSE

Temporarily relieves symptoms associated with overexertion or trauma, such as:

• muscle aches
• stiffness
• swelling from injuries
• bruising

OTHER SAFETY INFORMATION

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

INACTIVE INGREDIENT

Inactive Ingredients: Non-GMO glycerin 10% v/v, organic alcohol 20% v/v, purified water.

INDICATIONS & USAGE

Temporarily relieves symptoms associated with overexertion or trauma, such as:

• muscle aches
• stiffness
• swelling from injuries
• bruising

° natural

° gluten & lactose free

° no artificial flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA POWER 
arnica montana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61096-1032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 41 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61096-1032-1	1 in 1 CARTON	03/08/2019
1		41 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/08/2019

Labeler - Eight and Company L.L.C (927364120)

Registrant - Eight and Company L.L.C (927364120)