Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 63940-163-86
- Packager: Liberty Procurement, Inc
- 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 September 25, 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
- WARNINGS
- Keep out of reach of children
-
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 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 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Disclaimer
-
principal display panel
COREVALUES
Compare to Listerine Total Care Fresh Mint*
Anticavity MOUTHWASH
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION
MULTIPLE BENEFITS
IN ONE RINSE:
- Helps prevent cavities
- Restores enamel
- Strengthens teeth
- Kills germs that cause bad breath
- Freshens breath
- Leaves mouth feeling clean
IMPORTANT:
Read directions for proper use.
Mint Flavor
1 LITER (1 QT 1.8 fl oz)
Sealed With Printed Neckband For Your Protection
-
INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 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:63940-163-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/06/2016 Labeler - Liberty Procurement, Inc (804085293) Registrant - Vi Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi Jon, LLC 790752542 manufacture(63940-163)