Label: ORAL B MOUTH SORE SPECIAL CARE RINSE- sodium fluoride rinse
- NDC Code(s): 37000-962-08, 37000-962-16
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 17, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
- Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
- For temporary use to cleanse canker sores.
- Warnings
-
Directions
• adults and children 6 yrs. & older:
Rinse with 20 mL
Swish around in the mouth over the affected area for at least 1 minute and then spit out.
Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor.
do not swallow
- children 6 years to under 12 years of age:
supervise use
- children under 6 years of age:
do not use
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
ORAL B MOUTH SORE SPECIAL CARE RINSE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-962 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 0.03 mL in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-962-16 475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/02/2020 2 NDC:37000-962-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/02/2020 Labeler - The Procter & Gamble Manufacturing Company (004238200)