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Aquaflora High Potency 9

Aquaflora High Potency 9

Approved
Approval ID

cbfc0284-4501-4e0e-847f-5f7748077e97

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.

Abies canadensis, Agaricus muscarius, Allium cepa, Allium sativum, Aloe, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosis, Carpinus betulus, flos, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Malus pumila, flos, Olea europaea, flos, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-1814
Product Classification
G
Generic Name
Abies canadensis, Agaricus muscarius, Allium cepa, Allium sativum, Aloe, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosis, Carpinus betulus, flos, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Malus pumila, flos, Olea europaea, flos, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis.
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (35)

TSUGA CANADENSIS BARKActive
Quantity: 12 [hp_X] in 236 mL
Code: R53V5F950S
Classification: ACTIB
AMANITA MUSCARIA FRUITING BODYActive
Quantity: 12 [hp_X] in 236 mL
Code: DIF093I037
Classification: ACTIB
ONIONActive
Quantity: 12 [hp_X] in 236 mL
Code: 492225Q21H
Classification: ACTIB
GARLICActive
Quantity: 12 [hp_X] in 236 mL
Code: V1V998DC17
Classification: ACTIB
ALOEActive
Quantity: 12 [hp_X] in 236 mL
Code: V5VD430YW9
Classification: ACTIB
ANTIMONY TRISULFIDEActive
Quantity: 12 [hp_X] in 236 mL
Code: F79059A38U
Classification: ACTIB
FERULA ASSA-FOETIDA RESINActive
Quantity: 12 [hp_X] in 236 mL
Code: W9FZA51AS1
Classification: ACTIB
SODIUM BORATEActive
Quantity: 12 [hp_X] in 236 mL
Code: 91MBZ8H3QO
Classification: ACTIB
CANDIDA ALBICANSActive
Quantity: 12 [hp_X] in 236 mL
Code: 4D7G21HDBC
Classification: ACTIB
CANDIDA PARAPSILOSISActive
Quantity: 12 [hp_X] in 236 mL
Code: 0KZ676D44N
Classification: ACTIB
CARPINUS BETULUS FLOWERING TOPActive
Quantity: 12 [hp_X] in 236 mL
Code: QOI241B01F
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 12 [hp_X] in 236 mL
Code: 1NM3M2487K
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 12 [hp_X] in 236 mL
Code: C88X29Y479
Classification: ACTIB
MALUS DOMESTICA FLOWERActive
Quantity: 12 [hp_X] in 236 mL
Code: EF626V855K
Classification: ACTIB
OLEA EUROPAEA FLOWERActive
Quantity: 12 [hp_X] in 236 mL
Code: 498M34P1VZ
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 12 [hp_X] in 236 mL
Code: E4GA8884NN
Classification: ACTIB
PULSATILLA VULGARIS WHOLEActive
Quantity: 12 [hp_X] in 236 mL
Code: I76KB35JEV
Classification: ACTIB
SCHOENOCAULON OFFICINALE SEEDActive
Quantity: 12 [hp_X] in 236 mL
Code: 6NAF1689IO
Classification: ACTIB
LOBARIA PULMONARIAActive
Quantity: 12 [hp_X] in 236 mL
Code: D1YM0P5Z2T
Classification: ACTIB
SULFURActive
Quantity: 12 [hp_X] in 236 mL
Code: 70FD1KFU70
Classification: ACTIB
THUJA OCCIDENTALIS LEAFY TWIGActive
Quantity: 12 [hp_X] in 236 mL
Code: 1NT28V9397
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
LACHESIS MUTA VENOMActive
Quantity: 12 [hp_X] in 236 mL
Code: VSW71SS07I
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 12 [hp_X] in 236 mL
Code: 11E6VI8VEG
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/29/2022

image description High Potency 9.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/29/2022

Equal volumes of each HPUS** ingredient in 12X,
30X, 100X, and 1LM potencies.

Abies canadensis .................gnawing hunger, irritable,
peculiar cravings, light-headed
Agaricus muscarius ....... gastric disturbances, bloating
Allium cepa............................burning in mouth, throat,
bladder, and skin
Allium sativum ...............................constipation, cough
Aloe ...................................... headache, pain, nausea
Antimonium crudum .....................ear ringing, pimples,
coated tongue
Asafoetida .......... alcohol cravings, bloating, flatulence
Borax..............................nervousness, intestinal upset
Candida albicans..................... yeast infections, thrush
Candida parapsilosis...nail fungus, spacey, itchy scalp
Carpinus betulus, flos......................fatigue, weariness
Ignatia amara ......................... changeable mood, rash
Lachesis mutus ................ melancholy, sleeplessness,
food sensitivity
Lycopodium clavatum................ forgetfulness, drowsy,
sensitive to odors, stress, fear
Malus pumila, flos.........................obsessive cleansing
Olea europaea, flos.....................complete exhaustion
Phosphoricum acidum.................. nervous exhaustion,
listlessness
Phytolacca decandra....................scaly scalp, dry skin
Pulsatilla........................... overly emotional, chilliness,
daytime sleepiness
Sabadilla...................cravings for sweets and starches
Sticta pulmonaria............frothy stools, diarrhea, cough
Sulphur......................................... cravings for sweets,
milk and sweets disagree
Thuja occidentalis.................... GI irritation, brittle nails

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

Reference image: High Potency 9.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/29/2022

Keep out of reach of children.

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

Reference image: High Potency 9.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/29/2022

Directions

Bottle contains approximately 45 adult doses.

Adults: 1 measuring teaspoon, 2 times daily on an empty stomach, before
breakfast and at bedtime.

Children 6-12 years: 1/2 measuring teaspoon, 2 times daily on an
empty stomach, before breakfast and at bedtime.

Reference image: High Potency 9.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/29/2022

Other Information

Tamper resistant for your protection**.** Use
only if seal is intact.

King Bio, Inc. FDA Reg. #1053442
3 Westside Dr. Asheville, NC 28806 USA
Questions? Call 866.298.2740

Reference image: High Potency 9.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/29/2022

Inactive ingredients

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

Reference image: High Potency 9.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/29/2022

Active Ingredient

Equal volumes of each HPUS** ingredient in 12X,
30X, 100X, and 1LM potencies.

Abies canadensis, Agaricus muscarius, Allium cepa, Allium sativum, Aloe, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosis, Carpinus betulus, flos, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Malus pumila, flos, Olea europaea, flos, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis.

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

Reference image: High Potency 9.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/29/2022

Use

Temporarily relieves symptoms due to
overgrowth of Candida albicans yeast:

yeast infections

thrush

nail fungus

constipation

headache

nausea

itchy scalp

fatigue

diarrhea

flatulence

forgetfulness

sleeplessness

cravings

† 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: High Potency 9.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 9/29/2022

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: High Potency 9.jpg

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Aquaflora High Potency 9 - FDA Drug Approval Details