MedPath
FDA Approval

1 Bladder

The Wellness Center for Research and Education, Inc. (DUNS: 832363993)

May 28, 2025

HUMAN OTC DRUG LABEL

berberis vulgaris root bark(3 [hp_X] in 1 mL)
thuja occidentalis leaf(30 [hp_C] in 1 mL)
pulsatilla vulgaris(200 [hp_C] in 1 mL)
delphinium staphisagria seed(200 [hp_C] in 1 mL)
bryonia alba root(1 [hp_X] in 1 mL)
Calcium sulfide(1 [hp_X] in 1 mL)
Barium(1 [hp_X] in 1 mL)
Apis mellifera venom(200 [hp_C] in 1 mL)

Registrants (1)

Apotheca Company

844330915

Manufacturing Establishments (1)

Apotheca Company

The Wellness Center for Research and Education, Inc.

Apotheca Company

844330915

Products (1)

1 Bladder

50181-0037

ORAL

May 28, 2025

berberis vulgaris root barkActive
Code: 1TH8Q20J0UClass: ACTIBQuantity: 3 [hp_X] in 1 mL
thuja occidentalis leafActive
Code: 0T0DQN8786Class: ACTIBQuantity: 30 [hp_C] in 1 mL
pulsatilla vulgarisActive
Code: I76KB35JEVClass: ACTIBQuantity: 200 [hp_C] in 1 mL
delphinium staphisagria seedActive
Code: 00543AP1JVClass: ACTIBQuantity: 200 [hp_C] in 1 mL
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 1 [hp_X] in 1 mL
Code: 1MBW07J51QClass: ACTIBQuantity: 1 [hp_X] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
BariumActive
Code: 6P669D8HQ8Class: ACTIBQuantity: 1 [hp_X] in 1 mL
Code: 7S82P3R43ZClass: ACTIBQuantity: 200 [hp_C] in 1 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

INDICATIONS:

For temporary relief of irritation.

DOSAGE & ADMINISTRATION SECTION

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.


WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

For temporary relief of irritation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - QUESTIONS SECTION

QUESTIONS:

MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484


INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol


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