HOMEOPATHIC ARNICA DROPS- arnica montana 12x lozenge

Homeopathic Arnica Drops by

Drug Labeling and Warnings

Homeopathic Arnica Drops by is a Otc medication manufactured, distributed, or labeled by Historical Remedies LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Natural Homeopathic Arnica 12X

PURPOSE

Indications

For temporary relief of aching, strained muscles, bumps and bruises. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warning

If symptoms persist more than 7 days or worsen, consult a physician.

Keep out of children’s reach. In case of overdose, get medical help or contact a poison control center right away.

If pregnant or breast-feeding, ask a doctor before use.
Do not use if shrink wrap is broken or missing.

KEEP OUT OF REACH OF CHILDREN

Directions 

Adults & children over 8: dissolve one lozenge in mouth. Repeat every half hour as needed.

Inactive Ingredients:

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, tangerine flavor.

4 calories per lozenge. 1 gram sugar per lozenge.
No gluten added. Vegan.

Product label

INGREDIENTS AND APPEARANCE

HOMEOPATHIC ARNICA DROPS 
arnica montana 12x lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57556-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LEMON OIL (UNII: I9GRO824LL)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	14mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57556-002-01	30 in 1 BOX; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2020

Labeler - Historical Remedies LLP (627758634)

Establishment
Name	Address	ID/FEI	Business Operations
Historical Remedies LLP		627758634	manufacture(57556-002)