ARNICA PLUS- arnica montana, hamamelis virginiana bark and toxicodendron pubescens leaf gel
Peaceful Mountain, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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 breastfeeding, 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 conditions worsens, symptoms last more than 7 days.

DIRECTIONS

Apply at least 3 times daily over the affected area.

INACTIVE INGREDIENTS

Aloe Vera 10X Concentrate, Arnica (Flower) Arnica Montana, Carbomer (ULTREZ 21), Harpagophytum Procumbens (root), Edetate Disodium (EDTA), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14 (Silsense, Copolyol 1 Silicone), Mentha Piperita (leaf), Phenoxyethanol and Caprylyl Glycol, Sorbic Acid (Optiphen Plus), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Ascorbic Acid, Vitamin E Oil (derived from Soy Bean), Salix Alba (bark), Hamamelis Virginiana.

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.

INDICATIONSAND USAGE

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

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

peaceful mountain

THE HEIGHT OF HEALTH

arnica plus

homeopathic gel

paraben free

organic and

wild crafted herbs

formulated in boulder, co

Net wt. 4 lbs. (64 oz.) (1.8 kg)

Arnica Plus

ARNICA PLUS
arnica montana, hamamelis virginiana, rhus toxicodendron gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0026
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (ARNICA MONTANA)	ARNICA MONTANA	6 [hp_X] in 1 g
HAMAMELIS VIRGINIANA BARK (HAMAMELIS VIRGINIANA BARK)	HAMAMELIS VIRGINIANA BARK	6 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X] in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
ARNICA MONTANA FLOWER
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
HARPAGOPHYTUM PROCUMBENS ROOT
EDETATE DISODIUM
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER
PEG-8 DIMETHICONE
POLYETHYLENE GLYCOL 1500
POLYETHYLENE GLYCOL 700
MENTHA PIPERITA LEAF
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
POTASSIUM SORBATE
WATER
SODIUM HYDROXIDE
ASCORBIC ACID
ALPHA-TOCOPHEROL
SALIX ALBA BARK

Packaging
#	Item Code	Package Description
1	NDC:43846-0026-1	1814 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/11/2012

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0026)