Berberis Prunus
FDA Label NDC 48951-2148

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Berberis Prunus (NDC 48951-2148). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Under age 2: Consult a doctor.

Dosage & Administration

Directions: Apply to skin in and around nose as needed.

Otc - Active Ingredient

Active Ingredients: 100 gm contains: 50 gm Prunus spinosa (Blackthorn) 1X; Berberis (Barberry) 1X, Citrus (Lemon) 2X, Cydonia (Quince) 2X

Inactive Ingredient

Inactive Ingredients: Lanolin, Organic olive oil, Sunflower seed oil, Beeswax, Cajeput oil, Colloidal silica, Eucalyptus oil, Organic cane alcohol, Citric acid, Sorbic acid, Tea tree oil, Peruvian balsam, Grapefruit seed extract

"prepared using rhythmical processes"

Otc - Purpose

Use: Temporary relief of nasal congestion.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

KEEP OUT OF REACH OF CHILDREN
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal on bag is broken or missing.

Otc - Questions

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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