Dioscorea Batata
FDA Label NDC 48951-4178

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 Dioscorea Batata (NDC 48951-4178). 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

Directions: FOR TOPICAL USE ONLY.

Dosage & Administration

Apply to skin as needed. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Myrrha (Myrrh resin) 9X, Olibanum (Rubber resin from wood of incense tree) 9X, Aurum (Metallic gold) 12X, Dioscorea batata (Chinese yam) 16X

Inactive Ingredient

Inactive Ingredients: Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Stearyl alcohol, Xanthan gum, Sorbic acid, Tea tree oil, Frankincense oil, Myrrh oil, Rose oil, Grapefruit seed extract

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: FOR EXTERNAL USE ONLY.
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 is broken or missing.

Otc - Questions

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