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FDA Approval

Back, Muscle and Joint Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
King Bio Inc.
DUNS: 617901350
Effective Date
May 20, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Horse chestnut(10 [hp_X] in 59 mL)
bellis perennis whole(10 [hp_X] in 59 mL)
bryonia alba root(10 [hp_X] in 59 mL)
Calcium fluoride(10 [hp_X] in 59 mL)
Black cohosh(10 [hp_X] in 59 mL)
Cobalt(10 [hp_X] in 59 mL)
pseudognaphalium obtusifolium whole(10 [hp_X] in 59 mL)
Potassium carbonate(10 [hp_X] in 59 mL)
Dipotassium phosphate(10 [hp_X] in 59 mL)
Phosphorus(10 [hp_X] in 59 mL)
toxicodendron pubescens leaf(10 [hp_X] in 59 mL)
ruta graveolens flowering top(10 [hp_X] in 59 mL)
Zinc(10 [hp_X] in 59 mL)
Arnica montana flower(10 [hp_X] in 59 mL)
Ostrea edulis shell(10 [hp_X] in 59 mL)
Hypericum perforatum Extract(10 [hp_X] in 59 mL)
Magnesium phosphate(10 [hp_X] in 59 mL)
Oxalic Acid(10 [hp_X] in 59 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

King Bio Inc.

617901350

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products1

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

Back, Muscle and Joint Relief

Product Details

NDC Product Code
57955-2822
Route of Administration
ORAL
Effective Date
May 20, 2025
Horse chestnutActive
Code: 3C18L6RJAZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bellis perennis wholeActive
Code: 2HU33I03UYClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Calcium fluorideActive
Code: O3B55K4YKIClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Black cohoshActive
Code: K73E24S6X9Class: ACTIBQuantity: 10 [hp_X] in 59 mL
CobaltActive
Code: 3G0H8C9362Class: ACTIBQuantity: 10 [hp_X] in 59 mL
pseudognaphalium obtusifolium wholeActive
Code: 36XQ854NWWClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Potassium carbonateActive
Code: BQN1B9B9HAClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Dipotassium phosphateActive
Code: CI71S98N1ZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
PhosphorusActive
Code: 27YLU75U4WClass: ACTIBQuantity: 10 [hp_X] in 59 mL
toxicodendron pubescens leafActive
Code: 6IO182RP7AClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ruta graveolens flowering topActive
Code: N94C2U587SClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0TClass: IACT
ORANGE PEELInactive
Code: TI9T76XD44Class: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Arnica montana flowerActive
Code: O80TY208ZWClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Ostrea edulis shellActive
Code: 2E32821G6IClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Hypericum perforatum ExtractActive
Code: XK4IUX8MNBClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Magnesium phosphateActive
Code: HF539G9L3QClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Oxalic AcidActive
Code: 0K2L2IJ59OClass: ACTIBQuantity: 10 [hp_X] in 59 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

INDICATIONS & USAGE SECTION

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

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

WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY INFORMATION

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

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

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