Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
- NDC Code(s): 56062-163-86
- Packager: Publix Super Markets, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- WARNINGS
- Keep out of reach of children.
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Directions
Adults and children 12 years of age and older:
- use twice daily after brushing your teeth with 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
- supervise children as necessary until capable of using without supervision
- children under 12 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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principal display panel
Publix
EUCALYPTUS MINT
anticavity
FLUORIDE MOUTHWASH
Sodium Fluoride and Acidulated Phosphate Topical Solution
- Helps prevent cavities
- Restores enamel
- Helps strengthen teeth
- Helps kill germs that cause bad breath
Compare to the active ingredient in Listerine Total Care Anticavity Mouthwash*
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
1 L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) menthol (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) THYMOL (UNII: 3J50XA376E) 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:56062-163-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/20/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 07/20/2011 Labeler - Publix Super Markets, Inc (006922009) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(56062-163) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(56062-163)