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THERABREATH TOOTHPASTE

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 24mg in 10g
Labeler: 220 LABORATORIES INC
NDC Code: 57367-033

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.

ThereBreath Packaging

Directions: Cover the bristles of a dry tooth brush with TheraBreath Toothpaste and brush teeth, tongue, and palate for 2 minutes.

Keep out of reach of children.

If spilled on fabrics, wash out immediately. This product was sealed with protective packaging at the laboratory. If seal is missing, do not use.

Naturally Oxygenating

Professional Formula
TheraBreath
Dentist Recommended
Fresh Breath
Toothpaste

No Sodium Lauryl Sulfate
With Aloe Vera for Health Gums
Works Instantly - Reverses Dry Mouth
24 HR Confidence Guaranteed

THERABREATH TOOTHPASTE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-033
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE24 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
SILICON DIOXIDE 
GLYCERIN 
SODIUM PYROPHOSPHATE 
CARRAGEENAN 
XYLITOL 
SODIUM LAUROYL SARCOSINATE 
SODIUM BENZOATE 
SODIUM CHLORITE 
ALOE 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (PEPPERMINT OIL) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57367-033-18113.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/03/2010
Labeler - 220 LABORATORIES INC (783247950)
Registrant - 220 LABORATORIES INC (783247950)
Establishment
NameAddressID/FEIOperations
220 LABORATORIES INC783247950manufacture

Revised: 03/2010
Document Id: 3cc1078d-c61a-4b3c-877f-e0cbb6e7b9e7
Set id: bcb43ec7-5ef2-4a37-8a3c-1895cea58c36
Version: 1
Effective Time: 20100303
 
220 LABORATORIES 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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