MUSCLE RESCUE- arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel

MUSCLE RESCUE by

Drug Labeling and Warnings

MUSCLE RESCUE 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:

Arnica Montana 3X, Rhus Toxicodendron 3X, Phytolacca Decandra 12X, Pulsatilla 12X, Ruta Graveolens 12X.

INDICATIONS:

For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury.

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 using and ask doctor if​ - Condition worsens - Symptoms last more than 7 days.

DIRECTIONS:

Apply at least 3 times daily over the affected area. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Aloe Vera 10X Concentrate, Arnica Montana, Carbomer, Symphytum Officinale, Edetate Disodium, Natural Plant Extract, PEG-33, PEG-8, PEG-14, Phenodroxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purified Water, Sodium Hydroxide, Vitamin C, Vitamin E Oil, White Willow, Witch Hazel.

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:

For temporary relief of minor symptoms of muscle aches, pain from overexertion, and injury.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

peaceful mountain

muscle rescue

homeopathic gel

Net wt. 4 lbs (64 oz.) (1.8 kg)

INGREDIENTS AND APPEARANCE

MUSCLE RESCUE 
arnica montana, rhus toxicodendron, phytolacca decandra, pulsatilla, ruta graveolens gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	3 [hp_X]  in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	12 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
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)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0035-1	1814 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/07/2013

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0035) , api manufacture(43846-0035) , label(43846-0035) , pack(43846-0035)