HYDROGEN PEROXIDE ORAL RINSE liquid

Hydrogen Peroxide Oral Rinse by

Drug Labeling and Warnings

Hydrogen Peroxide Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Den-Mat Holdings, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Hydrogen peroxide 1.5% (w/v)

PURPOSE

Bacteria reducing rinse and oral debriding agent/oral wound cleanser

INDICATIONS & USAGE

For temporary use to reduce bacteria in the mouth before and after dental procedures. Other uses include removal of oral debris and cleansing or healing of minor mouth irritations, such as canker sores, minor wounds and minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury or other irritations of the mouth and gums.

WARNINGS

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

WHEN USING

do not swallow

STOP USE

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 68-77° (20-25°C)

INACTIVE INGREDIENT

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

QUESTIONS

800-433-6628

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE ORAL RINSE 
hydrogen peroxide oral rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-201
Route of Administration	ORAL

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
SODIUM FLUORIDE (UNII: 8ZYQ1474W7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MINT (UNII: FV98Z8GITP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-201-28	3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/17/2020
2	NDC: 59883-201-64	1893 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/17/2020
3	NDC: 59883-201-16	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/17/2020

Labeler - Den-Mat Holdings, LLC (809857704)

Establishment
Name	Address	ID/FEI	Business Operations
Den-Mat Holdings, LLC		809857704	manufacture(59883-201) , pack(59883-201) , label(59883-201)