The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Urosode (NDC 43406-0720). 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, warnings, dosage & administration, references, inactive ingredient, otc - questions, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS - equal amounts of: Uva Ursi 12C, Berber Vulg 30C, Boletus Sat 30C, Candida Alb 30C, Cantharis 30C, Equisetum Hyem 30C, Lachesis 30C, Oophorinum 30C, Saccharmoyces Cerevisiae 30C, Solidago 30C, Staphysagria 30C.
USES: Temporary relief of pain, burning, urinary frequency & Urgency.**
WARNINGS:
Consult a physician for use in children under 12 years of age.
IF PREGNANT OR BREAST-FEEDING, ask a health 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.
DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a heath care professional.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.
INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.
QUESTIONS & COMMENTS?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
USES: Temporary relief of pain, burning, urinary frequency & urgency.**
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.
NDC: 43406-0720-1
UROSODE
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
UPC: 87730002952
Image Description (Urosode)
* Please review the disclaimer below.
