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OraBrite

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: Oraline, Inc.
NDC Code: 54371-471

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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


ORABRITE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54371-471
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA 
SORBITOL 
WATER 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:54371-471-0124 g in 1 TUBE
2NDC:54371-471-0243 g in 1 TUBE
3NDC:54371-471-0378 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/31/2011
Labeler - Oraline, Inc. (179259361)
Registrant - Oraline, Inc. (179259361)
Establishment
NameAddressID/FEIOperations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.527127383manufacture(54371-471)

Revised: 11/2012
 
Oraline, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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