Search by Drug Name or NDC

NDC 57520-0311-01 Joint Rescue 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

Joint Rescue 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Joint Rescue is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Apotheca Company. The primary component is CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP.

Product Information

NDC	57520-0311
Product ID	57520-0311_c1a445b8-fbf0-4b99-9304-dac51e087a71
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Joint Rescue
Proprietary Name Suffix	n/a
Non-Proprietary Name	Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens,
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	6; 12; 3; 6; 12; 12
Active Ingredient Units	[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Substance Name	CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP
Labeler Name	Apotheca Company
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 57520-0311-01 (57520031101)

Pricing Information	N/A
NDC Package Code	57520-0311-1
Billing NDC	57520031101
Package	100 g in 1 TUBE (57520-0311-1)
Marketing Start Date	2011-03-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2e95b59e-2074-44fb-aaa7-2c38230b45cc Details

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS: Symphytum officinale 3X, Capsicum annuum 6X, Ledum palustre 6X, Colchicum autumnale 12X, Rhododendron chrysanthum 12X, Ruta graveolens 12X.

SPL UNCLASSIFIED SECTION

INDICATIONS: For temporary relief of minor symptoms of joint pain and inflammation.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS: Aloe vera concentrate, Arnica montana flower, Carbomer, Celery seed, Comfrey leaf, Demineralized water, Devil's claw root, Edetate disodium, Feverfew leaf, Oregano, Sage, PEG-33, PEG-8, Dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Poke root, Potassium sorbate, Sodium hydroxide, Turneric root, Vitamin C, Vitamin E oil, White willow bark.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

INDICATIONS: For temporary relief of minor symptoms of joint pain and inflammation.

SPL UNCLASSIFIED SECTION

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PRINCIPAL DISPLAY PANEL

joint rescue

organic and wild-crafted herbs

peaceful mountain

THE HEIGHT OF HEALTH

homeopathic gel

paraben-free

Formulated in boulder, co

unscented non-greasy no petroleum no animal testing

Net wt. 3.5 oz. (100 g)

INGREDIENTS AND APPEARANCE

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:57520-0311
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 VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
CELERY SEED (UNII: 1G1EAA320L)
COMFREY LEAF (UNII: DG4F8T839X)
WATER (UNII: 059QF0KO0R)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FEVERFEW (UNII: Z64FK7P217)
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)
SAGE (UNII: 065C5D077J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TURMERIC (UNII: 856YO1Z64F)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0311-1	100 g in 1 TUBE; Type 0: Not a Combination Product	03/11/2011	06/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/11/2011	06/30/2023

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0311) , api manufacture(57520-0311) , label(57520-0311) , pack(57520-0311)

Revised: 4/2022

Document Id: c1a445b8-fbf0-4b99-9304-dac51e087a71

Set id: 2e95b59e-2074-44fb-aaa7-2c38230b45cc

Version: 2

Effective Time: 20220426

Search by Drug Name or NDC

NDC 57520-0311-01 Joint Rescue 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Details

Joint Rescue 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g

Product Information

Package

Package Images

NDC 57520-0311-01 (57520031101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2e95b59e-2074-44fb-aaa7-2c38230b45cc Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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