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

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Drug Facts

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

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

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0026-1	1814 g in 1 JUG; Type 0: Not a Combination Product	10/11/2012	04/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/11/2012	04/10/2019

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

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

Revised: 9/2016

Document Id: 95fd158c-5cf2-4cfc-8d2b-0500da9128be

Set id: 2c36be0e-ddf5-4f96-b5b2-6f75881a1e34

Version: 2

Effective Time: 20160929

Peaceful Mountain, Inc.