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

Arnica Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Arnica montana 6X, 12X, Hamamelis virginiana 6X, 12X, Rhus toxicodendron 6X, 12X.

PURPOSE

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

WARNINGS

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 this product - Do not get into eyes.

Stop use and ask a doctor if - Condition worsens - Symptoms last more than 7 days.

DOSAGE & ADMINISTRATION

DIRECTIONS:  Apply at least 3 times daily over the affected area.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Aloe vera concentrate, Arnica flower, Carbomer (Ultrez 21), Devil's Claw root, Edetate disodium, Origanum vulgare, Salvia officinalis, PEG-33, PEG-8, Dimethicone, PEG-14, Peppermint leaf, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide solution, Vitamin C, Vitamin E (soy), White willow bark, Witch hazel bark.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

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, gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0630
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 (55000 MPA.S) (UNII: 59TL3WG5CO)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
SAGE (UNII: 065C5D077J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
DIMETHICONE (UNII: 92RU3N3Y1O)
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: 57520-0630-1	105 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/20/2011

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture