Label: PREVENTION MOUTH RINSE- hydrogen peroxide liquid
- NDC Code(s): 69951-002-16
- Packager: Prevention Health Sciences, Inc.
- 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 October 1, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- first aid to help reduce the risk of infection in minor cuts and scrapes caused by
- dentures
- dental procedures
- orthodontic appliances
- accidental injury
- aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth
- for temporary use to cleanse canker sores, minor wounds and gum irritation
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- adults and children 2 years of age and older: swish one capful (10 ml) around in mouth over affected area for at least one minute and then spit out
- use up to 4 times daily, after meals and at bedtime or as directed by a dentist or doctor
- children under 12 should be supervised in the use of product.
- children under 2 years of age: consult a dentist or doctor.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREVENTION MOUTH RINSE
hydrogen peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69951-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM CITRATE (UNII: 1Q73Q2JULR) ZINC CHLORIDE (UNII: 86Q357L16B) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69951-002-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/01/2023 Labeler - Prevention Health Sciences, Inc. (968930540)