Calendula Thuja
FDA Label NDC 48951-3253

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 Calendula Thuja (NDC 48951-3253). 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.

Indications & Usage

Under age 2: Consult a doctor.

Dosage & Administration

Directions: Fill the provided applicator with 2 to 3 grams of gel and apply at bedtime for 14 nights.

Otc - Active Ingredient

Active Ingredients: Calendula 2X, Echinacea (Purple coneflower) 2X, Marjorana (Marjoram) 2X, Lilium tigrinum (Tiger lily) 3X, Thuja (American arborvitae) 3X, Kreosotum (Creosote) 6X, Pulsatilla (Pasqueflower) 6X, Argentum colloidal (Colloidal silver) 7X, Candida albicans (Yeast) 30X

Inactive Ingredient

Inactive Ingredients: Distilled water, Glycerin, Boric acid, Sodium alginate, Sodium hydroxide, Lactic acid, Eucalyptus oil, Rosemary oil, Sage oil, Thyme oil, Tea tree oil, Grapefruit seed extract

Otc - Purpose

Use: Temporary relief of vaginal itching and irritation.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

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 seals on box are broken or missing. BEST WHEN USED WITHIN 30 DAYS OF OPENING.

Otc - Questions

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

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