ARNICARE- arnica montana gel

Arnicare by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Arnica montana 1X HPUS 7%

The letters HPUS indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Arnica montana 1X HPUS Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE

For relief of muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain and swelling as well as discoloration from bruising.

WARNINGS

For external use only

When using this product
Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Use only as directed

dryness or irritation may occur

do not tightly wrap or bandage the treated area

do not apply heat or ice to treated area immediately before or after use.

DO NOT USE

Do not use if glued carton and flaps are open or if the tube seal is broken.

ASK DOCTOR

STOP USE

condition persists for more than 3 days or worsens

symptoms clear up and occur again within a few days.

DOSAGE & ADMINISTRATION

Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare

INACTIVE INGREDIENT

Alcohol, carbomer, sodium hydroxide. purified water

HOW SUPPLIED

Tube 2.6, 1.5, 4.1 or .5 OZ

STORAGE AND HANDLING

Store at 68-77 O F (20-25 O C)

QUESTIONS

Questions, Comments?

www.boironusa.com

info@boironusa.com

1-800-BOIRON-1 (1-800-264-7661)

Boiron Information Center
6 Campus Boulevard
Newtown Square, PA 19073-3267

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

WHEN USING

DRUG INTERACTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9000
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)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9000-66	1 in 1 PACKAGE	01/09/2007
1		120 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0220-9000-59	1 in 1 PACKAGE	01/09/2007
2		75 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0220-9000-54	1 in 1 PACKAGE	01/09/2007
3		45 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0220-9000-65	1 in 1 PACKAGE	01/09/2007
4		14 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 0220-9000-84	1 in 1 PACKAGE	06/01/2018
5		45 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 0220-9000-86	2 in 1 PACKAGE	06/01/2018
6		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		01/09/2007

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9000)