The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Unda 42 (NDC 62106-1141). 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, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Each drop contains equal parts of:
Aconitum napellus (Aconite) Whole Plant 4X
Arnica montana (Mountain arnica) Root 4X
Aurum metallicum (Gold) 12X
Cuprum metallicum (Copper) 12X
Gelsemium sempervirens (Yellow jessamine) Root 4X
Uses
For the relief of symptoms
associated with minor back pain.
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.
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.
Indications
For the relief of symptoms associated with minor back pain.
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.
Contents may not fill package in order
to accommodate required labeling.
Please rely on stated quantity.
Inactive Ingredients:
Ethanol (beet),
purified water
NDC 62106-1141-8
UNDA
numbered compounds
UNDA 42
Homeopathic Preparation
For the temporary relief of symptoms
associated with minor back pain.
Contains 31% Alcohol
0.7 fl oz (20 mL)
* Please review the disclaimer below.
