ARNICA PLUS- arnia montana, hamamelis virginiana, rhus toxicodendron, gel 
Apotheca Company

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 the 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 concentrate, Arnica montana flower, Carbomer, Demineralized water, Devil's claw (root), Edetate disodium, Origanum vulgare, Salvia officinalis, PEG-33, PEG-8, Dimethicone, PEG-14, Peppermint (leaf), Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Sodium hydroxide, Vitamin C, Vitamin E oil, White willow (bark), Witch hazel (bark).

KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact a Poison Control Center right away.


INDICATIONS:  For the temporary relief of minor symptoms of sore, overexerted muscles.

Dist by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

unscented

non-greasy

no petroleum

no animal testing

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 
arnia montana, hamamelis virginiana, rhus toxicodendron, gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0392
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA12 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK12 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SAGE (UNII: 065C5D077J)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0392-11893 mL in 1 JUG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/08/201101/11/2017
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0392) , api manufacture(57520-0392) , label(57520-0392) , pack(57520-0392)

Revised: 8/2015
Document Id: 5420de00-20ec-42f1-9e61-57142b969d07
Set id: afc838eb-caac-4140-9172-888ab97ac387
Version: 3
Effective Time: 20150827
 
Apotheca Company