Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 69842-548-86
- Packager: CVS Pharmacy, 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 April 25, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warning
- Keep out of Reach of Children
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Directions
Adults and children 6 years of age and older:
- use twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- 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
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.
This product is not intended to replace brushing or flossing
Distributed by:
CVS Pharmacy Inc.
One CVS Drive
Woonsocket, RI 02895
(c)2021 CVS/pharmacy
CVS.com
1-800-SHOP CVS
CVS Quality money back guarantee
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Principal display panel
CVS Health
Compare to Listerine Total Care Zero Anticavity Mouthwash*
Alcohol Free
Anticavity Fluoride
Mouthwash
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION
6 Benefits:
- Restores enamel
- Helps prevent cavities
- Cleans the entire mouth
- Kills bad breath germs
- Strengthens teeth
- Freshens breath
- Fresh mint
Sealed with printed neckband for your protection. Do not use if broken or missing.
IMPORTANT: read directions for proper use
1L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-548 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM BENZOATE (UNII: OJ245FE5EU) PHOSPHORIC ACID (UNII: E4GA8884NN) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) THYMOL (UNII: 3J50XA376E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) menthol (UNII: L7T10EIP3A) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SUCRALOSE (UNII: 96K6UQ3ZD4) SPEARMINT OIL (UNII: C3M81465G5) PEPPERMINT OIL (UNII: AV092KU4JH) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-548-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/20/2021 Labeler - CVS Pharmacy, Inc (062312574) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(69842-548) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(69842-548)