TENDON RESCUE- bryonia, ruta graveolens, bellis perennis, argentum metallicum gel

Tendon Rescue by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Bryonia 3X, 12X, Ruta Graveolens 3X, 12X, Bellis Perennis 6X, Argentum Metallicum 30X.

INDICATIONS:

For temporary relief of symptoms of tendon and soft tissue discomfort.

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.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Aloe Vera Concentrate, Arnica Montana Flower, Carbomer, Symphytum Officinale Leaf, Edetate Disodium, Oregano, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Purfied Water, Rosmarinus Officinalis (leaf), Sodium Hydroxide Solution, Ascorbic Acid, Vitamin E Oil.

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS:

For temporary relief of symptoms of tendon and soft tissue discomfort.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PACKAGE LABEL DISPLAY

peaceful mountain

THE HEIGHT OF HEALTH

tendon rescue

homeopathic gel

paraben-free

organic and wild-crafted herbs

formulated in boulder, co

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

INGREDIENTS AND APPEARANCE

TENDON RESCUE 
bryonia, ruta graveolens, bellis perennis, argentum metallicum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	3 [hp_X]  in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	6 [hp_X]  in 1 g
SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	SILVER	30 [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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ROSEMARY (UNII: IJ67X351P9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0001-1	1814 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/21/2013

Labeler - Peaceful Mountain (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0001) , api manufacture(43846-0001) , label(43846-0001) , pack(43846-0001)