Label: THERABREATH HEALTHY GUMS ORAL RINSE- cetylpyridinium chloride rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 72551-247-01, 72551-247-04, 72551-247-05, 72551-247-06, view more72551-247-07, 72551-247-08, 72551-247-09 - Packager: Dr. Harold Katz, LLC
- Category: HUMAN OTC DRUG LABEL
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 February 1, 2022
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- Active Ingredient
- Purpose
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- Warnings
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- Other Information
- Inactive Ingredients
- TheraBreath Healthy Gums Oral Rinse
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERABREATH HEALTHY GUMS ORAL RINSE
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72551-247 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.0005 g in 1 g Inactive Ingredients Ingredient Name Strength POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white (Clear) Score Shape Size Flavor MINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72551-247-01 473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2020 2 NDC:72551-247-04 33.8 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2020 3 NDC:72551-247-05 88.7 g in 1 POUCH; Type 0: Not a Combination Product 12/01/2020 4 NDC:72551-247-06 958.21 g in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 5 NDC:72551-247-07 283.5 g in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 6 NDC:72551-247-08 85.05 g in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 7 NDC:72551-247-09 7.09 g in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2020 01/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/01/2020 Labeler - Dr. Harold Katz, LLC (965507767)