The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 23 (NDC 62106-1122). 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, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Equisetum arvense (Common horsetail) Stem 5X
Hypericum perforatum (St. John's Wort) Whole Plant 5X
Nux vomica (Poison nut) Seed 6X (< 2.7 x 10-6 % alkaloids, calculated)
Quercus robur (Common oak) Bark 6X
Tormentilla (Bloodwort) Underground Parts 6X
Uses
For the temporary relief of symptoms associated with
occasional incontinence
minor urinary discomfort
Warnings
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, 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.
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, 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.
Inactive ingredients
Ethanol (beet), purified water
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
Directions
Adults and adolescents (12 years and older)
Take 5 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
Uses
For the temporary relief of symptoms associated with
occasional incontinence
minor urinary discomfort
Directions
Adults and adolescents (12 years and older)
Take 5 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
NDC 62106-1122-8
UNDA
numbered compounds
UNDA 23
Homeopathic Preparation
For the temporary relief of symptoms associated
with occasional incontinence and minor urinary discomfort.
Contains 31% Alcohol
0.7 fl oz (20 mL)
* Please review the disclaimer below.
