ARNICARE- arnica montana cream

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

INDICATIONS & USAGE

Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.

DO NOT USE

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

DOSAGE & ADMINISTRATION

Apply a thin layer of Arnicare Cream to affected area and massage after minor injury. Repeat 3 times a day or as needed.

INACTIVE INGREDIENT

Arnicare Cream

Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

Arnicare Cream (without disodium EDTA)

Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

HOW SUPPLIED

Tube 2.5 OZ (70 G)
or
Tube 1.33 OZ (40G)

PURPOSE

Arnica Montana 1X ... Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising.

STORAGE AND HANDLING

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

QUESTIONS

Questions, Comments?

www.arnicare.com
www.boironusa.com

info@boironusa.com

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

Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA 19073-3267

ASK DOCTOR

STOP USE

Stop use and ask doctor if condition persists for more than 3 days or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

WHEN USING

DRUG INTERACTIONS

Unscented - Paraben-Free - Great for massage - Works naturally with your body

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 any of the this product's inactive ingredients.

When using this product, use only as directed: do not tightly wrap or bandage, do not apply heat or ice to the treated area immediately before or after use.

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE 
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9021
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 934 (UNII: Z135WT9208)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
ALCOHOL (UNII: 3K9958V90M)
HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9021-60	40 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2007
2	NDC: 0220-9021-63	70 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2007
3	NDC: 0220-9021-82	1 in 1 PACKAGE	06/01/2018
3		120 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		03/01/2007

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9021)