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

Arnica Plus by

Drug Labeling and Warnings

Arnica Plus by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

0.17% of Arnica Montana 6X, 12X, Hamamelis Virginiana 6X, 12X, Rhus Tox 6X, 12X

INDICATIONS:

May temporarily relieve minor symptoms of sore, overexerted muscles.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Extract Blend (Arnica (Arnica montana) Leaf, White Willow [Salix alba] Bark, Witch Hazel [Hamamelis virginiana] Bark, Ascorbic Acid, Devil’s Claw [Harpagophytum procumbens] Root, Peppermint [Mentha piperita] Leaf), Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33 (and) Peg-8 Dimethicone (and) Peg-14, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Sodium Hydroxide And 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

paraben-free

formulated in

boulder, co

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

ARNICA PLUS 
arnica montana, hamamelis virginiana, rhus tox gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [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 BARK	6 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0075-1	57 g in 1 TUBE; Type 0: Not a Combination Product	11/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/14/2018

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0075) , api manufacture(43846-0075) , label(43846-0075) , pack(43846-0075)