Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 50594-971-86
- Packager: Big Lots
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 20, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- 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 miute 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
- Questions?
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SPL UNCLASSIFIED SECTION
Sealed With Printed Neckband For Your Protection
This product is not intended to replace brushing or flossing
*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Zero Anticavity Mouthwash.
Manufactured for Big Lots By Vi-Jon, Inc.
8515 Page Avenue
St. Louis, MO 63114
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principal display panel
SOUNDBODY
Compare to the active ingredient in Listerine Total Care Zero Anticavity Mouthwash*
BURN FREE
Fluoride Anti-Cavity Mouthrinse
Sodium Fluoride and Acidulated Phosphate Topical Solution
Helps Strengthen Teeth to Fight Cavities
Helps Restore Enamel
Kill Bad Breath Germs
Freshens Breath
Cleans the Entire Mouth
Alcohol Free
IMPORTANT: read directions for proper use.
EUCALYPTUS 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:50594-971 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:50594-971-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 09/19/2017 Labeler - Big Lots (017885351) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(50594-971) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(50594-971)