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Arthritis Pain and Joint Relief

Arthritis Pain and Joint Relief

Approved
Approval ID

6e347366-a183-4d9a-981d-421be6278650

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-6163
Product Classification
G
Generic Name
Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (35)

ACTAEA SPICATA ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: 3FU86L9OS0
Classification: ACTIB
HORSE CHESTNUTActive
Quantity: 10 [hp_X] in 59 mL
Code: 3C18L6RJAZ
Classification: ACTIB
BELLIS PERENNIS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: 2HU33I03UY
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: T7J046YI2B
Classification: ACTIB
CALCIUM FLUORIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: O3B55K4YKI
Classification: ACTIB
CAUSTICUMActive
Quantity: 10 [hp_X] in 59 mL
Code: DD5FO1WKFU
Classification: ACTIB
BLACK COHOSHActive
Quantity: 10 [hp_X] in 59 mL
Code: K73E24S6X9
Classification: ACTIB
FORMIC ACIDActive
Quantity: 10 [hp_X] in 59 mL
Code: 0YIW783RG1
Classification: ACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIGActive
Quantity: 10 [hp_X] in 59 mL
Code: 877L01IZ0P
Classification: ACTIB
LITHIUM CARBONATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 2BMD2GNA4V
Classification: ACTIB
PHOSPHORUSActive
Quantity: 10 [hp_X] in 59 mL
Code: 27YLU75U4W
Classification: ACTIB
PULSATILLA VULGARIS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: I76KB35JEV
Classification: ACTIB
RHODODENDRON AUREUM LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: IV92NQJ73U
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: 6IO182RP7A
Classification: ACTIB
RUTA GRAVEOLENS FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: N94C2U587S
Classification: ACTIB
SALICYLIC ACIDActive
Quantity: 10 [hp_X] in 59 mL
Code: O414PZ4LPZ
Classification: ACTIB
ZINCActive
Quantity: 10 [hp_X] in 59 mL
Code: J41CSQ7QDS
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
ARNICA MONTANA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: O80TY208ZW
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 10 [hp_X] in 59 mL
Code: 2E32821G6I
Classification: ACTIB
HYPERICUM PERFORATUM WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: XK4IUX8MNB
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: 11E6VI8VEG
Classification: ACTIB
SEPIA OFFICINALIS JUICEActive
Quantity: 10 [hp_X] in 59 mL
Code: QDL83WN8C2
Classification: ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEActive
Quantity: 10 [hp_X] in 59 mL
Code: HF539G9L3Q
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/2/2022

image description Arthritis Pain and Joint.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/2/2022

Uses

Temporarily relieves symptoms:

Backache

Stiff, swollen joints

Leg cramps

Sore tendons and ligaments

Hip and knee discomforts

Irritability

Fatigue

Body aches

Restless limbs

As per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

Reference image:Arthritis Pain and Joint.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/2/2022

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3
times per day.

Consult a physician for use in
children under 6 years of age.

Use additionally as needed, up
to 6 times per day.

Reference image:Arthritis Pain and Joint.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/2/2022

Other information
Tamper resistant for your protection.
Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image: Arthritis Pain and Joint.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/2/2022

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image: Arthritis Pain and Joint.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/2/2022

Active ingredients

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum.

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Arthritis Pain and Joint.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 12/2/2022

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.
Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Arthritis Pain and Joint.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/2/2022

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Arthritis Pain and Joint.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/2/2022

Equal volumes of each HPUS ingredient in 10X, 30X, and 1LM
potencies.

Actaea spicata....................................................... fatigued joints
Aesculus hippocastanum ........................................ aching limbs
Arnica montana .........................................................body aches
Bellis perennis ............................................... muscular soreness
Bryonia ..................................................................... irritability
Calcarea carbonica ....................................................leg cramps
Calcarea fluorica ..........................................................backache
Causticum ............................................................. muscle aches
Cimicifuga racemosa..................................restless limbs, soreness
Formicum acidum......................................................... stiff joints
Hypericum perforatum.......................................... joint discomfort
Ledum palustre.............................................aching in lower limbs
Lithium carbonicum ................................... aching joints, stiffness
Magnesia phosphorica .................................................leg cramps
Phosphorus ..................................................................backache
Phytolacca decandra...................................................... stiffness
Pulsatilla .................................................hip and joint discomfort
Rhododendron chrysanthum ...................................achy shoulders
Rhus tox .......................................... sore tendons and ligaments
Ruta graveolens ...................................................... restlessness
Salicylicum acidum............................................ knee discomforts
Sepia ...................................................... stiffness, restless limbs
Zincum metallicum .......................................................backache

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States

Reference image:Arthritis Pain and Joint.jpg

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