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,

PURPOSE

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

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.

DIRECTIONS

Apply at least 3 times daily over the affected area.

INACTIVE INGREDIENTS

Aloe Vera 10X Concentrate, Arnica (flower) Arnica Montana, Carbomer (Ultrez21), Devil's Claw (root) Harpagophytum Procumbens, Edetat Disodium (EDTA), Natural Plant Extract (Origanox WS), PEG-33, PEG-8 Dimethicone, PEG-14, Peppermint (leaf) Mentha Piperita, Phenoxyethanol and Caprylyl Glycol and Sorbic Acid (Optiphen Plus), Potassium Sorbate, Purified Water, Sodium Hydroxide Solution, Vitamin C (Powder) Ascorbic Acid, Vitamin E Oil (derived from Soy Bean), White Willow (bark) Salix Alba, Witch Hazel (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.

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

formulated in boulder, co

Net wt. 0.25 oz. (7 g)

Arnica Plus

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus toxicodendron, gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0016
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
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)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0016-17 g in 1 PACKET; Type 0: Not a Combination Product09/19/201208/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/19/2012
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0016) , api manufacture(43846-0016) , label(43846-0016) , pack(43846-0016)

Revised: 9/2016
Document Id: 44a61d58-b8ea-452d-8c7a-1ccb569baa84
Set id: f4c45bfe-5975-4478-bac6-0a6e1bd7db01
Version: 2
Effective Time: 20160929
 
Peaceful Mountain, Inc.