ARNICA VALUE PACK- arnica montana kit

Arnica Value Pack by

Drug Labeling and Warnings

Arnica Value Pack 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

Arnicare Cream:

Arnica Montana 1X

Arnica 30 C pellets:
Arnica Montana 30C

INDICATIONS & USAGE

Arnicare cream and Arnica 30 C pellets
Temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.

INACTIVE INGREDIENT

Arnicare Cream Value Pack:

Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.

Pellets: Lactose, Sucrose.

Arnicare Cream Value Pack (without disodium EDTA):

Cream: alcohol, caprylyl, glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol.

Pellets: Lactose, Sucrose.

HOW SUPPLIED

Cream:
1 tube 2.5 OZ (70g)

Pellets:
1 tube approx. 80 pellets each, 3.8g (0.133 oz.)

PURPOSE

Cream:
Arnica Montana 1X HPUS-7% ..... Trauma, muscle, pain and stiffness, swelling from injuries, discoloration from bruising.

Pellets:
Arnica montana 30C HPUS .......... Trauma, bruises and muscle soreness.

STORAGE AND HANDLING

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

QUESTIONS

Questions, Comments
www.arnicare.com
info@boironusa.com
1-800-BOIRON-1
(1-800-264-7661)
Boiron Information Center
6 campus Bouelvard
Newtown Square, PA
19073-3267

ASK DOCTOR

STOP USE

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

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

KEEP OUT OF REACH OF CHILDREN

Cream:
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.

Pellets:
Keep out of reach of children

WHEN USING

DRUG INTERACTIONS

Unscented -Paraben free -Great for massage - Works naturally with your body.

WARNINGS

Arnicare Cream:

For external use only.

Avoid contact with eyes and with open wounds.

DOSAGE & ADMINISTRATION

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

Pellets:
Adults and children 2 years of age and older: Dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA VALUE PACK 
arnica montana kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9047

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9047-78	1 in 1 BOX	11/01/2008

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	80
Part 2	1 TUBE	70 g

Part 1 of 2

ARNICA 
arnica montana pellet

Product Information
Item Code (Source)	NDC: 0220-0508
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Pellet)	Size	4mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		80 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		11/01/2008

Part 2 of 2

ARNICARE 
arnica montana cream

Product Information
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		70 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		11/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/01/2008

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9047)