Otc - Purpose
Relieves pain, crankiness and crying during teething
Oral Soothe
FDA Label NDC 68647-165
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 Soothe (NDC 68647-165). 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 - purpose, indications & usage, dosage & administration, general precautions, otc - active ingredient, inactive ingredient, warnings, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Indications: Soothing homeopathic remedy for teething in babies and children.
Dosage & Administration
Dosage: Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.
General Precautions
Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.
Otc - Active Ingredient
Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)
Inactive Ingredient
Sucrose (inactive ingredient).
Warnings
Contains no gluten, artificial flavors, colors or preservatives.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. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: 1.877.289.1235
International: + 1.561.999.8857
The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.
Package Label.Principal Display Panel
Bottle Label (Oralsoothe)
Otc - Keep Out Of Reach Of Children
Keep this and all medicines from the reach of children.
* Please review the disclaimer below.
