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Back, Muscle and Joint Relief

Back, Muscle and Joint Relief

Approved
Approval ID

b4c23381-8bca-4159-98d5-557e188c14af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 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.

Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica,Oxalicum acidum, Phosphorus, Rhus tox, Ruta graveolens, Zincum metallicum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-2822
Product Classification
G
Generic Name
Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica,Oxalicum acidum, Phosphorus, Rhus tox, Ruta graveolens, Zincum metallicum
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (30)

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
BLACK COHOSHActive
Quantity: 10 [hp_X] in 59 mL
Code: K73E24S6X9
Classification: ACTIB
COBALTActive
Quantity: 10 [hp_X] in 59 mL
Code: 3G0H8C9362
Classification: ACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: 36XQ854NWW
Classification: ACTIB
POTASSIUM CARBONATEActive
Quantity: 10 [hp_X] in 59 mL
Code: BQN1B9B9HA
Classification: ACTIB
DIBASIC POTASSIUM PHOSPHATEActive
Quantity: 10 [hp_X] in 59 mL
Code: CI71S98N1Z
Classification: ACTIB
PHOSPHORUSActive
Quantity: 10 [hp_X] in 59 mL
Code: 27YLU75U4W
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
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
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEActive
Quantity: 10 [hp_X] in 59 mL
Code: HF539G9L3Q
Classification: ACTIB
OXALIC ACID DIHYDRATEActive
Quantity: 10 [hp_X] in 59 mL
Code: 0K2L2IJ59O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/15/2022

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/15/2022

Uses

For temporary relief of symptoms:

back discomforts

muscle tension and cramps

weakness and fatigue

joint stiffness

body aches

soreness

tired legs and feet restlessness

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:Back Muscle and Joint.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/15/2022

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:Back Muscle and Joint.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 11/15/2022

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:Back Muscle and Joint.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/15/2022

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:Back Muscle and Joint.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/15/2022

Active ingredients

Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica,Oxalicum acidum, Phosphorus, Rhus tox, Ruta graveolens, Zincum metallicum.

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

WARNINGS SECTION

LOINC: 34071-1Updated: 11/15/2022

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:Back Muscle and Joint.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/15/2022

Keep out of reach of children.

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

Reference image:Back Muscle and Joint.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/15/2022

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.
Aesculus hippocastanum .............................................. tired feet
Arnica montana ......................................body aches, restlessness
Bellis perennis ............................................... muscular soreness
Bryonia .....................................................................stiff joints
Calcarea carbonica ........................................... back discomforts
Calcarea fluorica .............................................. back discomforts
Cimicifuga racemosa............................................ leg discomforts
Cobaltum metallicum........................................................fatigue
Gnaphalium polycephalum...........................................leg cramps
Hypericum perforatum.......................................................aches
Kali carbonicum................................. muscle tension and stiffness
Kali phosphoricum........................................................tired legs
Magnesia phosphorica .....................................................fatigue
Oxalicum acidum.......................................................body aches
Phosphorus .................................................................backache
Rhus tox ....................................................................stiff joints
Ruta graveolens ........................................................body aches
Zincum metallicum ................................................. sore muscles
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

Reference image:Back Muscle and Joint.jpg

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Back, Muscle and Joint Relief - FDA Drug Approval Details