Label: THERABREATH TOOTHPASTE- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 57367-033-18 - Packager: 220 LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 3, 2010
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INGREDIENTS AND APPEARANCE
THERABREATH TOOTHPASTE
sodium fluoride gel, dentifriceProduct 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