Label: PREVENTION ONCOLOGY MOUTH RINSE- glycerin liquid
- NDC Code(s): 69951-001-03, 69951-001-16
- Packager: Prevention Health Sciences, Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
adults and children 2 years of age and older: gargle, swish around in the mouth over the affected area for at least one minute and then spit out. Use as needed or as directed by dentist or doctor.
children under 12 years of age should be supervised in the use of product.
children under 2: consult with a dentist or doctor.
- Other information
- Inactive ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTION ONCOLOGY MOUTH RINSE
glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69951-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 4.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM CITRATE (UNII: 1Q73Q2JULR) ZINC CHLORIDE (UNII: 86Q357L16B) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69951-001-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2023 2 NDC:69951-001-03 95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/10/2023 Labeler - Prevention Health Sciences, Inc. (968930540)