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1 Bladder

Drug Facts:

Approved
Approval ID

516fc6d9-9a4c-4adb-b0d5-d11af3a71fc9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

The Wellness Center for Research and Education, Inc.

DUNS: 832363993

Products 1

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

Berberis Vulgaris, Thuja Occidentalis, Apis Mellifica, Pulsatilla, Staphysagria, Baryta Carbonica, Bryonia, Hepar Sulphuris Calcareum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50181-0037
Product Classification
G
Generic Name
Berberis Vulgaris, Thuja Occidentalis, Apis Mellifica, Pulsatilla, Staphysagria, Baryta Carbonica, Bryonia, Hepar Sulphuris Calcareum
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (10)

BERBERIS VULGARIS ROOT BARKActive
Quantity: 3 [hp_X] in 1 mL
Code: 1TH8Q20J0U
Classification: ACTIB
THUJA OCCIDENTALIS LEAFActive
Quantity: 30 [hp_C] in 1 mL
Code: 0T0DQN8786
Classification: ACTIB
PULSATILLA VULGARISActive
Quantity: 200 [hp_C] in 1 mL
Code: I76KB35JEV
Classification: ACTIB
DELPHINIUM STAPHISAGRIA SEEDActive
Quantity: 200 [hp_C] in 1 mL
Code: 00543AP1JV
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 1 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
CALCIUM SULFIDEActive
Quantity: 1 [hp_X] in 1 mL
Code: 1MBW07J51Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BARIUM CARBONATEActive
Quantity: 1 [hp_X] in 1 mL
Code: 6P669D8HQ8
Classification: ACTIB
APIS MELLIFERAActive
Quantity: 200 [hp_C] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/15/2016

PACKAGE LABEL DISPLAY:

Dr. Theresa Dale's

NDC: 50181-0037-1

Homeopathic

Neuro-EmotionalRemedies

#1 BLADDER

Irritated

1 fl oz (30 ml)

1 Bladder

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/3/2014

INDICATIONS:

For temporary relief of irritation.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/15/2016

ACTIVE INGREDIENTS:

Berberis Vulgaris 3X, Thuja Occidentalis 30C, Apis Mellifica 200C, Pulsatilla (Vulgaris) 200C, Staphysagria 200C, Baryta Carbonica 1M, Bryonia (Alba) 1M, Hepar Sulphuris Calcareum 1M.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/3/2014

INDICATIONS:

For temporary relief of irritation.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/3/2014

WARNINGS:

**​If pregnant or breast-feeding,**​ ask a health professional before use.

**​Keep out of reach of children.**​ In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/3/2014

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/3/2014

DIRECTIONS:

Feel the emotion fully, breathe deeply-connecting breaths. Put 5 drops under tongue to release emotion. Continue 5 drops 2x daily as needed. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/3/2014

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/3/2014

QUESTIONS:

MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

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1 Bladder - FDA Drug Approval Details