DENMAT HYDROGEN PEROXIDE ORAL RINSE- hydrogen peroxide oral rinse rinse 
Den-Mat Holdings, LLC

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Drug Facts

Hydrogen peroxide 1.5% (w/v)........

Bacteria reducing rinse and oral debriding agent/oral wound cleanser

For temporary use to reduce bacteria in the mouth to cleanse or facilitate healing of minor mouth irritations, such as canker sores, minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury or other irritations of the mouth and gums.

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
■ sore mouth symptoms do not improve within 7 days
■ irritation, pain or redness persists or worsens
■ swelling, rash or fever develops

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 6 years of age and older: fill dose cup to 10 mL (two
teaspoons) and rinse around in the mouth over affected area for
at least 1 minute, then spit out
Use up to 4 times daily after meals and at bedtime or as directed by
a dentist or physician
Children under 12 years of age should be supervised in the use of
the product
Children under 6 years of age: consult a dentist or physician

Other information store at controlled room temperature 68 – 77ºF
(20 – 25ºC)

Inactive Ingredients Water, glycerin, sodium citrate, cremophor RH 40,
flavor, tego betain ZF, citric acid, sodium benzoate, sodium fluoride,
xylitol.

Questions? 800-433-6628

64 oz back label64 oz front label

DENMAT HYDROGEN PEROXIDE ORAL RINSE 
hydrogen peroxide oral rinse rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59883-202
Route of AdministrationTOPICAL
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
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
MINT (UNII: FV98Z8GITP)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM FLUORIDE (UNII: 8ZYQ1474W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59883-202-641893 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/02/202212/29/2023
2NDC:59883-202-283785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/02/202212/29/2023
3NDC:59883-202-16473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/02/202212/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02205/02/202212/29/2023
Labeler - Den-Mat Holdings, LLC (809857704)
Registrant - Den-Mat Holdings, LLC (809857704)
Establishment
NameAddressID/FEIBusiness Operations
Den-Mat Holdings, LLC809857704manufacture(59883-202) , label(59883-202) , pack(59883-202)

Revised: 12/2023
 
Den-Mat Holdings, LLC