Urosode
FDA Label NDC 43406-0090

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Urosode (NDC 43406-0090). 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, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS - equal amounts of: Uva Ursi 12C, Berber Vulg 30C, Boletus Sat 30C, Borrelia 30C, Candida Alb 30C, Cantharis 30C, Chlamydia 30C, Equisetum Hyem 30C, Lachesis 30C, Lymphogranuloma 30C, Oophorinum 30C, Saccharomyces Cerevisiae 30C, Solidago 30C, Staphysagria 30C.

Indications & Usage

USES: Temporary relief of pain, burning, urinary frequency & urgency.**

Otc - Purpose

USES: Temporary relief of pain, burning, urinary frequency & urgency.**

Dosage & Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

Otc - Questions

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Package Label.Principal Display Panel

NDC:43406-0090-1

Urosode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Image Description (Urosode)

Image Description (Urosode)

* Please review the disclaimer below.