THERABREATH TOOTHPASTE- sodium fluoride gel, dentifrice

THERABREATH TOOTHPASTE by

Drug Labeling and Warnings

THERABREATH TOOTHPASTE by is a Otc medication manufactured, distributed, or labeled by 220 LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

Keep out of reach of children.

GENERAL PRECAUTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

THERABREATH TOOTHPASTE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57367-033
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	24 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARRAGEENAN (UNII: 5C69YCD2YJ)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORITE (UNII: G538EBV4VF)
ALOE (UNII: V5VD430YW9)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT (PEPPERMINT OIL)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57367-033-18	113.5 g in 1 TUBE

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	Business Operations
220 LABORATORIES INC		783247950	manufacture