CLOSYS- hydrogen peroxide rinse 
Rowpar Pharmaceuticals, Inc.

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CloSYS Mouth Sores Oral Rinse

Drug Facts

Active ingredient

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral debriding agent
Oral wound cleanser

Uses

Warnings

Do not use this product for more than 7 days unless directed by a dentist, or physician.

When using this product, do not swallow.

Stop use and ask a doctor if

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older

Children 6 years to under 12 years of age: supervise use

Children under 6 years of age: do not use

Other Information

Inactive ingredients

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions or comments?

call 1-800-643-3337

Packaging

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS®
Oral Debriding Agent

MOUTH
SORES


SENSITIVE
MOUTH RINSE

PROMOTES HEALING

HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION

For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation

Non Burning, Alcohol-Free
Formula

Gentle Mint

16 fl oz (473mL)

52516-75

Front Label

Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

52516-76

Back Label
CLOSYS 
hydrogen peroxide rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0613
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Sucralose (UNII: 96K6UQ3ZD4)  
Edetate Disodium (UNII: 7FLD91C86K)  
Menthol, Unspecified Form (UNII: L7T10EIP3A)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58578-0613-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/27/2025
2NDC:58578-0613-51 in 1 CARTON01/01/2026
2473 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58578-0613-73 in 1 PACKAGE11/18/2025
3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/27/2025
Labeler - Rowpar Pharmaceuticals, Inc. (783704661)
Establishment
NameAddressID/FEIBusiness Operations
Geodis Logistics LLC116937615pack(58578-0613)

Revised: 12/2025
Document Id: 2db642d7-8842-4aac-9deb-6cdbd4d9f955
Set id: 299fc7b1-af6d-4bf9-810f-d35283423fe2
Version: 2
Effective Time: 20251217
 
Rowpar Pharmaceuticals, Inc.