Hydrogen Peroxide Oral Rinse by Den-Mat Holdings, LLC

Drug Details [pdf]

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

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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Drug Facts

Hydrogen peroxide 1.5% 9w/v

Bacteria reducing rinse and oral debriding agent/oral wound cleanser

For temporary use to reduce bactria 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.

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

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

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

Directions

Adults and children 2 years of ge and older: fill dose cup to 10 mL (two teaspoons) and rinse around in the mouth over affected area for at lest 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 2 years of age: consult a dentist or physician

Other Information

store at controlled room temperature 68-77 ° (20-25°C)

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

800-433-6628

16 oz label

HYDROGEN PEROXIDE ORAL RINSE
hydrogen peroxide, oral rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-200
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 in 100

Ingredient Name	Strength
Inactive Ingredients
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MINT (UNII: FV98Z8GITP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 59883-200-28	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020
2	NDC: 59883-200-29	2 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020
3	NDC: 59883-200-64	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020
4	NDC: 59883-200-65	2 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020
5	NDC: 59883-200-16	1 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020
6	NDC: 59883-200-17	6 in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/18/2020	08/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	06/18/2020	08/07/2020

Labeler - Den-Mat Holdings, LLC (809857704)

Name	Address	ID/FEI	Business Operations
Establishment
Den-Mat Holdings, LLC		809857704	manufacture(59883-200) , pack(59883-200) , label(59883-200)

Revised: 8/2020

Document Id: ad441b53-53b2-c14a-e053-2995a90ae098

Set id: a8777d78-785a-a865-e053-2995a90a7634

Version: 2

Effective Time: 20200819