MUSCLE RESCUE (arnica montana, rhus tox, whey protein, phytolacca decandra, pulsatilla- vulgaris, 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 Tox 3X, Whey Protein 6X, Phytolacca Decandra 12X, Pulsatilla (Vulgaris) 12X, Ruta Graveolens 12X

INDICATIONS:

May temporarily relieve minor symptoms of muscle aches, pain from overexertion, and injury.**

**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.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve minor symptoms of muscle aches, pain from overexertion, and injury.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Purified Water, Grape Seed Oil (Vitis Vinifera), When Protein, Lecithin (Soy), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Arnica Montana Flower, Comfrey Leaf, White Willow Bark, Polysorbate 20, Witch Hazel Bark, Sodium Hydroxide, Ascorbic Acid, Vitamin E Oil, Edetate Disodium (EDTA), Oregano, Potassium Sorbate

QUESTIONS:

Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579

888-303-3388
www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

muscle rescue

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben free

formulated in boulder, co

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

MUSCLE RESCUE 
arnica montana, rhus tox, whey protein, phytolacca decandra, pulsatilla (vulgaris), ruta graveolens gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0052
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
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	6 [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) (ANEMONE PULSATILLA - 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
WATER (UNII: 059QF0KO0R)
GRAPE SEED OIL (UNII: 930MLC8XGG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
SALIX ALBA BARK (UNII: 205MXS71H7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0052-1	57 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/07/2016

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0052) , api manufacture(43846-0052) , label(43846-0052) , pack(43846-0052)