JOINT RESCUE- symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens gel
Peaceful Mountain, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Symphytum Officinale 3X, Capsicum Annuum 6X, Ledum Palustre 6X, Colchicum Autumnale 12X, Rhododendron Chrysanthum 12X, Ruta Graveolens 12X.

INDICATIONS:

For temporary relief of minor symptoms of joint pain and inflammation.**

**These statements are based upon traditional homeopathic practice. 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- Condition worsens - Symptoms last more than 7 days.

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

INDICATIONS:

For temporary relief of minor symptoms of joint pain and inflammation.**

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

INACTIVE INGREDIENTS:

Aloe Vera, Arnica Montana, Carbomer (Ultrez 21), Apium Graveolens, Symphytum Officinale, Harpagophytum Procumbes, Edetate Disodium (EDTA), Tanacetum Parthenium, Natural Plant Extract, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly Glycol, Sorbic Acid, Phytolacca Americana, Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Curcuma Longa, Vitamin C, Vitamin E, Salix Alba.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

joint rescue

peaceful mountain

homeopathic gel

Net wt. 3.7 oz. (105 g)

image description

JOINT RESCUE
symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0029
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [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
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	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

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CELERY SEED (UNII: 1G1EAA320L)
COMFREY LEAF (UNII: DG4F8T839X)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FEVERFEW (UNII: Z64FK7P217)
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)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TURMERIC (UNII: 856YO1Z64F)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0029-1	105 g in 1 TUBE; Type 0: Not a Combination Product	09/13/2013	07/20/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/13/2013	07/20/2022

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0029) , api manufacture(43846-0029) , label(43846-0029) , pack(43846-0029)

Revised: 12/2021

Document Id: 58de93b6-6dbe-4654-b77a-decccc95b406

Set id: cc24d04e-cd5e-4c0b-8852-f709525dc6eb

Version: 2

Effective Time: 20211213

Peaceful Mountain, Inc.