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.

----------

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, Whey Protein Concentrate (milk), Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Sodium Hydroxide (Solution), Edetate Disodium (EDTA), Arnica Montana, White Willow (bark), Witch Hazel (bark), Ascorbic Acid, Devil’s Claw (root), Peppermint (leaf).

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

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:43846-0069
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)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0069-157 g in 1 TUBE; Type 0: Not a Combination Product02/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/09/2018
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0069) , api manufacture(43846-0069) , label(43846-0069) , pack(43846-0069)

Revised: 2/2018
Document Id: e0f4ef27-5d40-4050-b06c-09440b03fa8f
Set id: a62b4f7a-12c3-4190-a579-24b1c6554131
Version: 1
Effective Time: 20180209
 
Peaceful Mountain, Inc.