ARNICARE BRUISE- arnica montana gel

Arnicare Bruise by

Drug Labeling and Warnings

Arnicare Bruise by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Arnica montana 1X

Purpose

Arnica montana 1X - Reduces pain, swelling and discoloration from bruising

Uses

Reduces pain, swelling and discoloration from bruises.

WARNINGS

For external use only

Avoid contact with eyes, mucous membranes, damaged skin or wounds

Do not use if

you are allergic to Arnica montana or to any of this product's inactive ingredients.

When using this product

• use only as directed
• do not banadage tightly or use a heating pad

Stop use and ask a doctor if

condition persists for more than 3 days or worsens.

Keep out of reach of children.

If swallowed,

get medical help or contact Poison Control Center right away.

Directions

Apply a thin layer of Arnicare Bruise to affected area and massage gently as soon as possible after or minor bruise. Repeat 3 times a day or as needed.

Other information

• do not use if glued carton end flaps are open or if the tube seal is broken

Inactive ingredients

Alcohol, carbomer, purified water, sodium hydroxide

Questions, Comments?

www.Arnicare.com
www.BoironUSA.com
info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA 19073-3267

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE BRUISE 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9084-54	1 in 1 PACKAGE	02/01/2016
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2016

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9084)