Label: LISTERINE SMART RINSE BERRY SPLASH- sodium fluoride mouthwash
- NDC Code(s): 69968-0606-3, 69968-0606-5
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
-
Directions
- Adults and children 6 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour in the cup.
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- replace cap promptly after use
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- Children under 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
NEW!
2X STRONGER TEETH
FOR BETTER CAVITY PROTECTION*
ANTICAVITY FLUORIDE RINSE
LISTERINE ®
SMART RiNSE ®
SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
ALCOHOL FREE*Versus brushing alone,
In a lab study.
IMPORTANT: Read
directions for proper use.ADA
Accepted
American
Dental
Association ®BERRY
SLASH
500 mL (16.9 fl oz)
-
INGREDIENTS AND APPEARANCE
LISTERINE SMART RINSE BERRY SPLASH
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0606 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PHOSPHORIC ACID (UNII: E4GA8884NN) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SUCRALOSE (UNII: 96K6UQ3ZD4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0606-5 500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/06/2020 09/08/2022 2 NDC:69968-0606-3 27 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 01/06/2020 Labeler - Kenvue Brands LLC (118772437)