The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 233 (NDC 62106-1160). 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 - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains:
Crataegus (Hawthorn) Fruit 4X
Hamamelis virginiana (Witch Hazel) Bark 4X
Rheum (Chinese Rhubarb) Underground Parts 4X.
Rhus toxicodendron (Poison Ivy) Shoots 4X
Uva-ursi (Bearberry) Leaf 4X
Uses
For the temporary relief of symptoms
associated with varicose veins.
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.
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
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 varicose vein problems.
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.
Other information
Do not use if seal is missing or broken.
Store in a cool, dry place.
NDC 62106-1160-8
UNDA
numbered compounds
UNDA 233
Homeopathic Preparation
Contains 31% Alcohol
0.7 fl oz (20 ml)
* Please review the disclaimer below.
