Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 41163-971-86
- Packager: United Natural Foods, Inc. dba UNFI
- 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 May 10, 2023
If you are a consumer or patient please visit this version.
- 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 (2 teaspoonfuls) 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
Sealed With Printed Neckband For Your Portection
Do Not Use If Band Around Cap Is Broken or Missing.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributer or Listerine Total Care Zero Alcohol Anticavity Fresh Mist Mouthwash.
Like it or let us make it right.
That's our quality promise.
855-423-2630
DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA
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Principal panel display
compare to Listerine Total Care Zero Alcohol Mouthwash active ingredient*
EQUALINE
Fluoride Anti-Cavity
Mouthwash
Sodium Fluoride and Acidulated
Phosphate Topical Solution
- alcohol-Free
- helps strengthen teeth to fight cavities
- helps restore enamel
- kills germs that couse bad breath
IMPORTANT: read directions for proper use.
FRESH MINT
1 L (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:41163-971 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 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) 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:41163-971-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/01/2021 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(41163-971) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(41163-971)