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Name:Therabreath Toothpaste
Manufacturer:220 Laboratories Inc
Category:Over-the-counter (OTC) Marketed Drugs


ThereBreath Packaging

THERABREATH TOOTHPASTE  - sodium fluoride gel, dentifrice 
220 LABORATORIES INC

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.

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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 TUBE


THERABREATH TOOTHPASTE 
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57367-033
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 24 mg  in 10 g
Inactive Ingredients
Ingredient Name Strength
WATER  
SORBITOL  
SILICON DIOXIDE  
GLYCERIN  
SODIUM PYROPHOSPHATE  
CARRAGEENAN  
XYLITOL  
SODIUM LAUROYL SARCOSINATE  
SODIUM BENZOATE  
SODIUM CHLORITE  
ALOE  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT (PEPPERMINT OIL) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57367-033-18 113.5 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/03/2010

Labeler - 220 LABORATORIES INC (783247950)
Registrant - 220 LABORATORIES INC (783247950)
Establishment
Name Address ID/FEI Operations
220 LABORATORIES INC 783247950 manufacture

Revised: 03/2010 220 LABORATORIES INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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