Label: REDDYPORT ANTISEPTIC ORAL RINSE- hydrogen peroxide mouthwash
REDDYPORT ANTIPLAQUE SOLUTION- cetylpyridinium chloride rinse
REDDYPORT NIV MAINTENANCE KIT- cetylpyridinium chloride and hydrogen peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 73573-005-15, 73573-015-15, 73573-155-14 - Packager: SMD Manufacturing
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 22, 2021
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REDDYPORT ANTISEPTIC ORAL RINSE
hydrogen peroxide mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73573-015 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SPEARMINT (UNII: J7I2T6IV1N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73573-015-15 14.8 mL in 1 CUP; Type 0: Not a Combination Product 01/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/22/2020 REDDYPORT ANTIPLAQUE SOLUTION
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73573-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BENZOIC ACID (UNII: 8SKN0B0MIM) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SORBITOL (UNII: 506T60A25R) SPEARMINT (UNII: J7I2T6IV1N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73573-005-15 14.8 mL in 1 CUP; Type 0: Not a Combination Product 01/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/22/2020 REDDYPORT NIV MAINTENANCE KIT
cetylpyridinium chloride and hydrogen peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73573-155 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73573-155-14 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/14/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 CUP, UNIT-DOSE 4 mL in 14.8 Part 2 0 CUP, UNIT-DOSE 2 mL in 14.8 Part 1 of 2 REDDYPORT ANTISEPTIC ORAL RINSE
hydrogen peroxide mouthwashProduct Information Item Code (Source) NDC:73573-015 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength SPEARMINT (UNII: J7I2T6IV1N) SACCHARIN SODIUM (UNII: SB8ZUX40TY) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/22/2021 Part 2 of 2 REDDYPORT ANTIPLAQUE SOLUTION
cetylpyridinium chloride rinseProduct Information Item Code (Source) NDC:73573-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) SPEARMINT (UNII: J7I2T6IV1N) BENZOIC ACID (UNII: 8SKN0B0MIM) SACCHARIN SODIUM (UNII: SB8ZUX40TY) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/14/2021 Labeler - SMD Manufacturing (070849038) Establishment Name Address ID/FEI Business Operations Elba, Inc. 108428483 manufacture(73573-005, 73573-015, 73573-155)
