MedPath
FDA Approval

Ear Ringing

King Bio Inc. (DUNS: 617901350)

May 19, 2025

HUMAN OTC DRUG LABEL

dysphania ambrosioides whole(10 [hp_X] in 59 mL)
Black cohosh(10 [hp_X] in 59 mL)
Coffea arabica seed, roasted(10 [hp_X] in 59 mL)
Potassium Iodide(10 [hp_X] in 59 mL)
kalmia latifolia leaf(10 [hp_X] in 59 mL)
Magnesium carbonate(10 [hp_X] in 59 mL)
Sodium Salicylate(10 [hp_X] in 59 mL)
Salicylic acid(10 [hp_X] in 59 mL)
allylthiourea(10 [hp_X] in 59 mL)
thyroid, unspecified(10 [hp_X] in 59 mL)
Quinine(10 [hp_X] in 59 mL)
Arnica montana flower(10 [hp_X] in 59 mL)
Ostrea edulis shell(10 [hp_X] in 59 mL)
Manganese(10 [hp_X] in 59 mL)
Manganese(10 [hp_X] in 59 mL)
Para-Mercury-Benzenesulfonic Acid(10 [hp_X] in 59 mL)

Registrants (1)

King Bio Inc.

617901350

Manufacturing Establishments (1)

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products (1)

Ear Ringing

57955-5276

ORAL

May 19, 2025

dysphania ambrosioides wholeActive
Code: 4H5RSU087IClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Black cohoshActive
Code: K73E24S6X9Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Coffea arabica seed, roastedActive
Code: 9H58JRT35EClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Potassium IodideActive
Code: 1C4QK22F9JClass: ACTIMQuantity: 10 [hp_X] in 59 mL
kalmia latifolia leafActive
Code: 79N6542N18Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Magnesium carbonateActive
Code: 0E53J927NAClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Sodium SalicylateActive
Code: WIQ1H85SYPClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Salicylic acidActive
Code: O414PZ4LPZClass: ACTIBQuantity: 10 [hp_X] in 59 mL
allylthioureaActive
Code: 706IDJ14B7Class: ACTIBQuantity: 10 [hp_X] in 59 mL
thyroid, unspecifiedActive
Code: 0B4FDL9I6PClass: 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
QuinineActive
Code: 6DY04L71DRClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Arnica montana flowerActive
Code: O80TY208ZWClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Ostrea edulis shellActive
Code: 2E32821G6IClass: ACTIBQuantity: 10 [hp_X] in 59 mL
ManganeseActive
Code: 9ZV57512ZMClass: ACTIMQuantity: 10 [hp_X] in 59 mL
ManganeseActive
Code: 9TO51D176NClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Para-Mercury-Benzenesulfonic AcidActive
Code: FXS1BY2PGLClass: ACTIBQuantity: 10 [hp_X] in 59 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description Ear Ringing.jpg

INDICATIONS & USAGE SECTION

Uses

Uses for symptomatic relief of ear sounds:

Buzzing

Roaring

Ringing

Whistling

Sensitivity to noise

† 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:Ear Ringing.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:Ear Ringing.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:Ear Ringing.jpg

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.

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

Reference image:Ear Ringing.jpg

OTC - PURPOSE SECTION

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

Arnica montana .......................................................dull hearing
Calcarea carbonica ............................................ cracking in ears
Chenopodium anthelminticum.......................auditory nerve issues
Chininum salicylicum..................................................ear ringing
Cimicifuga racemosa............................................noise sensitivity
Coffea tosta .............................................ringing, roaring in ears
Kali iodatum..................................................................ear pain
Kalmia latifolia .......................................................stiches in ear
Magnesia carbonica ........................................diminished hearing
Manganum aceticum ....................................................whistling
Manganum carbonicum...................................................earache
Mercurius vivus .......................................tinkling, buzzing sounds
Natrum salicylicum ................................................noises in ears
Salicylicum acidum........................................................deafness
Thiosinaminum ...................................................vertigo, tinnitus
Thyroidinum...........................................................ear disorders

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

Reference image:Ear Ringing.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:Ear Ringing.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:Ear Ringing.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:Ear Ringing.jpg

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