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FDA Approval

Sciatic Nerve Formula

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 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Horse chestnut(10 [hp_X] in 59 mL)
Ammonium chloride(10 [hp_X] in 59 mL)
Arsenic trioxide(10 [hp_X] in 59 mL)
Belladonna(10 [hp_X] in 59 mL)
Capsicum(10 [hp_X] in 59 mL)
causticum(10 [hp_X] in 59 mL)
colchicum autumnale bulb(10 [hp_X] in 59 mL)
citrullus colocynthis fruit pulp(10 [hp_X] in 59 mL)
pseudognaphalium obtusifolium whole(10 [hp_X] in 59 mL)
strychnos ignatii seed(10 [hp_X] in 59 mL)
kalmia latifolia leaf(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)
Hypericum perforatum Extract(10 [hp_X] in 59 mL)
Magnesium phosphate(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.

Sciatic Nerve Formula

Product Details

NDC Product Code
57955-6031
Route of Administration
ORAL
Effective Date
May 23, 2025
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
Horse chestnutActive
Code: 3C18L6RJAZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Ammonium chlorideActive
Code: 01Q9PC255DClass: ACTIMQuantity: 10 [hp_X] in 59 mL
Arsenic trioxideActive
Code: S7V92P67HOClass: ACTIBQuantity: 10 [hp_X] in 59 mL
BelladonnaActive
Code: WQZ3G9PF0HClass: ACTIBQuantity: 10 [hp_X] in 59 mL
CapsicumActive
Code: 00UK7646FGClass: ACTIBQuantity: 10 [hp_X] in 59 mL
causticumActive
Code: DD5FO1WKFUClass: ACTIBQuantity: 10 [hp_X] in 59 mL
colchicum autumnale bulbActive
Code: 993QHL78E6Class: ACTIBQuantity: 10 [hp_X] in 59 mL
citrullus colocynthis fruit pulpActive
Code: 23H32AOH17Class: ACTIBQuantity: 10 [hp_X] in 59 mL
pseudognaphalium obtusifolium wholeActive
Code: 36XQ854NWWClass: ACTIBQuantity: 10 [hp_X] in 59 mL
strychnos ignatii seedActive
Code: 1NM3M2487KClass: ACTIBQuantity: 10 [hp_X] in 59 mL
kalmia latifolia leafActive
Code: 79N6542N18Class: 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
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
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Hypericum perforatum ExtractActive
Code: XK4IUX8MNBClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Magnesium phosphateActive
Code: HF539G9L3QClass: 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 Sciatic Nerve Formula.jpg

INDICATIONS & USAGE SECTION

Uses

For temporary relief of symptoms:

  • Low back, leg, hip, and joint pain
  • Nerve inflammation
  • Numbness and tingling
  • Weakness in back and legs

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: Sciatic Nerve Formula.jpg

DOSAGE & ADMINISTRATION SECTION

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

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

Reference image: Sciatic Nerve Formula.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: Sciatic Nerve Formula.jpg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

Aesculus hippocastanum, Ammonium muriaticum, Arsenicum album, Belladonna, Capsicum annuum, Causticum, Colchicum autumnale, Colocynthis, Gnaphalium polycephalum, Ignatia amara, Hypericum perforatum, Magnesia phosphorica, Rhus tox, Ruta graveolens.

Reference image: Sciatic Nerve Formula.jpg

OTC - PURPOSE SECTION

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

Aesculus hippocastanum ................discomfort in back, legs, arms
Ammonium muriaticum.................... discomfort, tightness in hips
Arsenicum album................................uneasiness, fatigue in legs
Belladonna ..................................................discomfort in limbs
Capsicum annuum .............................................stiffness in legs
Causticum ..............................................discomfort with motion
Colchicum autumnale ........................ numbness, tingling in limbs
Colocynthis ......................................discomfort from hip to knee
Gnaphalium polycephalum ............................. discomfort in limbs
Hypericum perforatum .........................radiating pain down limbs
Ignatia amara ......................... weakness in back and lower limbs
Kalmia latifolia ...........low back pain, neuralgia shooting downward
Magnesia phosphorica ...................................... muscular fatigue
Rhus tox .......................................discomfort in legs, hips, joints
Ruta graveolens .........................................low back and leg pain

Reference image: Sciatic Nerve Formula.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: Sciatic Nerve Formula.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: Sciatic Nerve Formula.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: Sciatic Nerve Formula.jpg

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