REDDYPORT ANTISEPTIC ORAL RINSE- hydrogen peroxide mouthwash 
REDDYPORT ANTIPLAQUE SOLUTION- cetylpyridinium chloride rinse 
REDDYPORT NIV MAINTENANCE KIT- cetylpyridinium chloride and hydrogen peroxide 
SMD Manufacturing

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.

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Reddyport Q4 Maintenance Kit Artwork

Antiseptic Labeling

anti-plaque outer labeling

Anti-plaque outer labeling

Antiseptic Outer Labeling

Antiplaque indications

antiseptic indications

Antiplaque OTC children

Antiseptic OTC Children

Antiplaque Purpose

antiseptic purpose

Antiplaque Active Ingredient

Antiseptic Active

Anti-plaque ingredients

antiseptic ingredient

ReddyPort Antiplaque Solution Artwork

ReddyPort Antiseptic Oral Rinse

REDDYPORT ANTISEPTIC ORAL RINSE 
hydrogen peroxide mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73573-015
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SPEARMINT (UNII: J7I2T6IV1N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73573-015-1514.8 mL in 1 CUP; Type 0: Not a Combination Product01/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/22/2020
REDDYPORT ANTIPLAQUE SOLUTION 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73573-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73573-005-1514.8 mL in 1 CUP; Type 0: Not a Combination Product01/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/22/2020
REDDYPORT NIV MAINTENANCE KIT 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73573-155
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73573-155-141 in 1 KIT; Type 1: Convenience Kit of Co-Package01/14/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 CUP, UNIT-DOSE 4 mL  in 14.8 
Part 20 CUP, UNIT-DOSE 2 mL  in 14.8 
Part 1 of 2
REDDYPORT ANTISEPTIC ORAL RINSE 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:73573-015
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SPEARMINT (UNII: J7I2T6IV1N)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/22/2021
Part 2 of 2
REDDYPORT ANTIPLAQUE SOLUTION 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:73573-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
114 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/14/2021
Labeler - SMD Manufacturing (070849038)
Establishment
NameAddressID/FEIBusiness Operations
Elba, Inc.108428483manufacture(73573-005, 73573-015, 73573-155)

Revised: 1/2021
Document Id: b5aadaeb-6ed7-7d70-e053-2995a90ae760
Set id: 9cbe6206-88b6-f8ab-e053-2a95a90ae497
Version: 2
Effective Time: 20210122
 
SMD Manufacturing