ARNICA PLUS- arnica montana, hamamelis virginiana, rhus toxicodendron lotion

Arnica Plus by

Drug Labeling and Warnings

Arnica Plus by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Toxicodendron 6X, 12X

INDICATIONS

For temporary relief of minor symptoms of sore, overexerted muscles.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS

For external use only. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using the product - Do not get into eyes. Stop use and ask a doctor if - Condition worsens Symptoms last more than 7 days.

DIRECTIONS

Apply at least 3 times daily over the affected area.

INACTIVE INGREDIENTS

Aloe Vera, Arnica (flower), Carbomer, Devil's Claw, Edetate Disodium, Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14, Peppermint (leaf), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ascorbic Acid, Vitamin E Oil, White Willow, Witch Hazel (bark)

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS AND USAGE

For temporary relief of minor symptoms of sore, overexerted muscles.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PRINCIPAL DISPLAY PANEL

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in

boulder, co

Net wt. 3.7 oz. (105 g)

INGREDIENTS AND APPEARANCE

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus toxicodendron lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0032-1	105 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/04/2013

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0032)