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, Devil's claw root, Edetate disodium, Natural plant extract, PEG-33 and PEG -8, Dimethicone , PEG-14, Peppermint leaf, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sodium hydroxide, Vitamin C, Vitamin E (soy), White willow bark and 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

PRINCIPAL DISPLAY PANEL

peaceful mountain

THE HEIGHT OF HEALTH

organic and will crafted herbs

homeopathic gel

formulated in boulder, co

Net wt. 0.24 oz. (7 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0481
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	12 [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	12 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
WITCH HAZEL (UNII: 101I4J0U34)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)
SAGE (UNII: 065C5D077J)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57520-0481-1	7 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/13/2011

Labeler - Apotheca Company (844330915)

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