JOINT AND TENDON RESCUE (bryonia- alba, ruta graveolens, bellis perennis, capsicum annuum, ledum palustre, symphytum officinale, colchicum autumnale, rhododendron chrysanthum, argentum metallicum gel

Joint and Tendon Rescue by

Drug Labeling and Warnings

Joint and Tendon 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:

(in gel): 0.11% of Argentum Metallicum 30X, Bellis Perennis 6X, Bryonia (Alba) 3X, Capsicum Annuum 6X, Colchicum Autumnale 12X, Ledum Palustre 6X, Rhododendron Chrysanthum 12X, Ruta Graveolens 3X, Symphytum Officinale 6X

INDICATIONS:

May temporarily relieve minor symptoms of joint pain and inflammation and tendon and soft tissue discomfort.**

**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.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve minor symptoms of joint pain and inflammation and tendon and soft tissue discomfort.**

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

INACTIVE INGREDIENTS:

Purified Water, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Sodium Hydroxide (Solution), Acrylates/C10-30 Alkyl Acrylate Crosspolymer (Carbopol (Ultrez 21), PEG-33 (and) PEG-8 Dimethicone (and) PEG-14, Aloe Barbadensis Leaf Juice (Aloe Vera 10X Concentrate), Tocopherols [Vitamin E Oil] (derived from Soy Bean), Edetate Disodium (EDTA), Potassium Sorbate, Arnica (flower), Comfrey (leaf), White Willow (bark), Celery (seed), Devil’s Claw (root), Feverfew (leaf), Poke (root), Ascorbic Acid, Turmeric (Root).

QUESTIONS:

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

888-303-3388
www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

joint and tendon rescue
peaceful mountain
THE HEIGHT OF HEALTH
homeopathic gel
paraben-free
formulated in
boulder, co
Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

JOINT AND TENDON RESCUE 
bryonia (alba), ruta graveolens, bellis perennis, capsicum annuum, ledum palustre, symphytum officinale, colchicum autumnale, rhododendron chrysanthum, argentum metallicum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0077
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
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	6 [hp_X]  in 1 g
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 1 g
WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6)	WHEY	12 [hp_X]  in 1 g
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	12 [hp_X]  in 1 g
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	30 [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)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
SALIX ALBA BARK (UNII: 205MXS71H7)
CELERY SEED (UNII: 1G1EAA320L)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
FEVERFEW (UNII: Z64FK7P217)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0077-1	57 g in 1 TUBE; Type 0: Not a Combination Product	12/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/12/2018

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0077) , api manufacture(43846-0077) , label(43846-0077) , pack(43846-0077)