Active Ingredient
DRUG FACTS
ACTIVE INGREDIENT:
Sodium Fluoride 0.22%
(Total Fluoride Content - 1000 ppm approx.)
Orabrite
FDA Label NDC 54371-471
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oraline, Inc. for the product Orabrite (NDC 54371-471). 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 active ingredient, purpose, keep out of reach of children, use, warnings, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
PURPOSE: Anticavity Toothpaste.
Keep Out Of Reach Of Children
WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Use
USE: Helps protect against cavities.
Warnings
WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Directions
DIRECTIONS:
Adults and children 2 tears of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in god brushing and rinsing habits. (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
INACTIVE INGREDIENTS:
Hydrated Silica, Sorbitol, Deionized Water, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Lauryl Sulfate, Sodium Carboxymethylcellulose, Flavor, Sodium Saccharin.
Package Label
Distributed by Oraline Inc., 823 NYS RT 13, Cortland, N.Y. 13045
OraBrite
Mint Flavor with Fluoride
NET WT 1.50 oz.
Mfg. Date and Batch No. on crimp.
Product of China, produced for Oraline. 888-296-6730. www.oraline.net
Oraline Orabrite 2 Label (Oraline Orabrite2)
* Please review the disclaimer below.
