ARNICA PLUS- arnica montana, hamamelis virginiana, rhus tox, whey protein gel

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 Tox 6X, 12X, Whey Protein 6X, 12X

INDICATIONS:

May temporarily relieve minor symptoms of sore, overexerted muscles.**

**These statements are based upon traditional homeopathic principles. 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 this product Do not get into eyes.

Stop use and ask a doctor if Conditions worsens Symptoms last more than 7 days

Do not use if safety seal is broken or missing.

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.

DIRECTIONS:

Apply at least 3 times daily over the affected area.

INDICATIONS:

May temporarily relieve minor symptoms of sore, overexerted muscles.**

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

INACTIVE INGREDIENTS:

Purified Water, Vitis Vinifera (Grape Seed Oil), Whey Protein, Lecithin (Soy), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana (Flower), Aloe Barbadensis Leaf, Salix Alba Bark (White Willow), Polysorbate 20, Hamamelis Virginiana Bark (Witch Hazel), Sodium Hydroxide, Ascorbic Acid, Harpagophytum Procumbens Root (Devil’s Claw), Tocopherols (Soy), Mentha Piperita Leaf (Peppermint), Edetate Disodium, Oregano, Potassium Sorbate

QUESTIONS:

Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579
888-303-3388
www.peacefulmountain.com

patent pending

PACKAGE LABEL DISPLAY:

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)

INGREDIENTS AND APPEARANCE

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus tox, whey protein gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0065
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 BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY)	HAMAMELIS VIRGINIANA 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
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SALIX ALBA BARK (UNII: 205MXS71H7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
TOCOPHEROL (UNII: R0ZB2556P8)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0065-1	1814 g in 1 JUG; Type 0: Not a Combination Product	07/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/20/2016

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0065) , api manufacture(43846-0065) , label(43846-0065) , pack(43846-0065)