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

INDICATIONS:

May temporarily relieve 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 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.

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 practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Purified Water, Grapeseed (Seed) Carrier Oil, Whey Protein Concentrate, Lecithin (Soy) (Liquid)Sodium Hydroxide (Solution), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Arnica (flower), Aloe Barbadensis Leaf Juice, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Polysorbate 20, Tocopherol [Vitamin E Oil], Peppermint (leaf), Edetate Disodium (EDTA), Natural plant extract (Origanox WS), Potassium Sorbate.

QUESTIONS:

Dist. By Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

arnica

plus®

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

formulated in

boulder, co

Net wt. 2 oz. (57g)

Arnica Plus

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus tox gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0060
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
WHEY (UNII: 8617Z5FMF6)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
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)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OREGANO (UNII: 0E5AT8T16U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0060-157 g in 1 TUBE; Type 0: Not a Combination Product05/09/201608/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/09/2016
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0060) , api manufacture(43846-0060) , label(43846-0060) , pack(43846-0060)

Revised: 9/2016
Document Id: cc9415ce-40e7-492a-8743-83cd01ee5e46
Set id: d5cac1bc-b443-4518-b5b3-8188c2d00926
Version: 2
Effective Time: 20160929
 
Peaceful Mountain, Inc.