Label: BREATHAWAY MOUTH RINSE FRESH MINT- cetylpyridinium chloride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-294-08, 54473-294-16 - Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 30, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients
water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BREATHAWAY MOUTH RINSE FRESH MINT
cetylpyridinium chloride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-294 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.3394 g in 473 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) GLYCERIN (UNII: PDC6A3C0OX) MYRRH OIL (UNII: H74221J5J4) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) TEA TREE OIL (UNII: VIF565UC2G) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) ZINC CITRATE (UNII: K72I3DEX9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-294-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 2 NDC:54473-294-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2018 09/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/02/2011 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-294)