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

arnica plus

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

formulated in boulder, co

Net wt. 2 oz. (57 g)

Arnica Plus

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus tox, whey protein gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [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 BARK6 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]  in 1 g
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0061-157 g in 1 TUBE; Type 0: Not a Combination Product07/19/201606/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/19/201606/23/2022
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0061) , api manufacture(43846-0061) , label(43846-0061) , pack(43846-0061)

Revised: 5/2018
Document Id: 1c029cb8-e480-40d3-8c3a-06e5f1482c4a
Set id: 557d9e83-4677-4b43-a658-e34c8a70568f
Version: 2
Effective Time: 20180518
 
Peaceful Mountain, Inc.