Label: HYDROGEN PEROXIDE ORAL RINSE liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 59883-201-16, 59883-201-28, 59883-201-64 - Packager: Den-Mat Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
-
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
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDROGEN PEROXIDE ORAL RINSE
hydrogen peroxide oral rinse liquidProduct 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)
