ARNICARE- arnica montana cream

ARNICARE by

Drug Labeling and Warnings

ARNICARE by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. 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 you are allergic to Arnica Montana or to any of this product's inactive ingredients. Do not use if the tube seal is broken.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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 .5 OZ (14 G)

PURPOSE

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

STORAGE AND HANDLING

QUESTIONS

Questions, Comments?

www.Arnicare.com

www.BoironUSA.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

6 Campus Boulevard
Newtown Square, PA

19073-3267

ASK DOCTOR

Ask doctor if condition persists for more than 3 days or worsens.

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

When using this product

• Use only as directed
• Do not bandage lightly or use a heating pad.

SPL UNCLASSIFIED SECTION

• Ideal for Massage
• Soothing
• Unscented
• Paraben-Free

WARNINGS

For external use only. Avoid contact with eyes, mucous membranes, damaged skin or wounds.

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
HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9021-68	1 in 1 BOX	02/29/2016
1		14 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		02/29/2016

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

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