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  5. Label Information: Urosode

FDA Label for Urosode

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urosode Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.