ORABRITE- sodium fluoride paste, dentifrice

OraBrite by

Drug Labeling and Warnings

OraBrite by is a Otc medication manufactured, distributed, or labeled by Oraline, Inc., Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

DRUG FACTS

ACTIVE INGREDIENT:

Sodium Fluoride 0.22%

(Total Fluoride Content - 1000 ppm approx.)

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

INGREDIENTS AND APPEARANCE

ORABRITE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54371-471
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54371-471-01	24 g in 1 TUBE
2	NDC: 54371-471-02	43 g in 1 TUBE
3	NDC: 54371-471-03	78 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/31/2011

Labeler - Oraline, Inc. (179259361)

Registrant - Oraline, Inc. (179259361)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.		527127383	manufacture(54371-471)