1 Bladder
FDA Label NDC 57520-0220

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca, Company for the product 1 Bladder (NDC 57520-0220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Berberis vulgaris 3X, Thuja occidentalis 30C, Apis mellifica 200C, Pulsatilla 200C, Staphysagria 200C, Baryta carbonica 1M, Bryonia 1M, Hepar sulphuris calcareum 1M.

Otc - Purpose

INDICATIONS:  For the temporary relief of irritation.


Warnings

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.


Dosage & Administration

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

Inactive Ingredient

INACTIVE INGREDIENTS:  Demineralized water, 25% Alcohol


Otc - Questions


MFG. FOR:

Theresa Dale, N.D.

1237 S. Victoria Ave.

Oxnard, CA 93035

1-866-962-6484

Package Label.Principal Display Panel

Dr. Theresa Dale's

HOMEOPATHIC

Neuro-Emotional Remedies

#1 BLADDER

Irritated

1 fl oz (30 ml)

#1 Bladder (Mm1)

#1 Bladder (Mm1)


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