Oral Assist
FDA Label NDC 68647-172

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Feelgood Health for the product Oral Assist (NDC 68647-172). 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 description, dosage & administration, general precautions, otc - active ingredient, inactive ingredient, pregnancy, user safety warnings, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Relieves tooth discomfort

Dosage & Administration

Dosage: Mix 10 drops in ¼ cup water and sip slowly. Repeat 3-5 times daily as needed until symptoms subside. If preferred, drops may be taken directly into the mouth.

Children under 12: Reduce dosage to 5 drops, 3-5 times daily.

General Precautions

Caution: Consult your doctor if symptoms persist or worsen.

Keep this and all medicines out of reach of children

Otc - Active Ingredient

Ingredients: Each dose contains equal parts of Acidum salicylicum 6C (HPUS), Silicea 6X (HPUS), Belladonna 30C (HPUS), Merc sol 12C (HPUS), Ferrum phos 6X (HPUS), Hepar sulph 12C (HPUS),

Inactive Ingredient

Citricidal Extract (inactive ingredient).

Pregnancy

If pregnant or breastfeeding, ask a health professional before use.

User Safety Warnings

Contains no animal products, gluten, artificial flavors, preservatives, colorants or alcohol. Suitable for vegetarians and safe for all ages

Information For Patients

All Native Remedies health products are especially formulated by experts in the  field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Distributed by

Native Remedies, LLC

6531 Park of Commerce

Blvd.  Suite C-160

Boca Raton, FL 33487

Phone: +1.877.289.1235

International: +1.253.620.4542

Package Label.Principal Display Panel

Bottle Label (Oralassist)

Bottle Label (Oralassist)

Indications & Usage

Indications:Homeopathic remedy for short-term relief of tooth discomfort and boils.

* Please review the disclaimer below.