Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 72476-971-86
- Packager: RETAIL BUSINESS SERVICES, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- 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
DISTRIBUTED BY ADUSA DISTRIBUTION, LLC
SALISBURY, NC 28147
For product questions and concerns,
contact us at 1-833-992-3872
Quality guaranteed or your money back.
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Compare to Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*
BURN FREE FLUORIDE
ANTI-CAVITY MOTHWASH
SODIUM FLUORIDE AND ACIDULATED
PHOSPHATE TOPICAL SOLUTION
HELPS STRENGTHEN TEETH TO FIGHT CAVITIES
HELPS RESTORE ENAMEL
FRESH MINT FLAVOR
IMPORTANT: read directions for proper use.
NET 33.8 FL OZ (1.05 QT) 1L
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-971 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 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:72476-971-86 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/08/2022 Labeler - RETAIL BUSINESS SERVICES, LLC (967989935) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72476-971) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72476-971)