Label: ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 53942-163-86
- Packager: Demoulas Super Markets, 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 December 20, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Use
- Warnings
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Directions
Adults and children 12 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
- SPL UNCLASSIFIED SECTION
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principal panel display
"More for your dollar"
MARKET BASKET
Sealed With Printed Neckband For Your Protection
MARKET BASKET
Compare to Listerine Total Care Anticavity Mouthwash*
ANTICAVITY MOUTHWASH
Sodium Fluoride and Acidulated Phosphate Topical Solution
Eucalyptus Mint
• Helps prevent cavities
• Helps strengthen teeth
• Helps kill germs that cause bad breath
• Freshens breath
• Restores enamelIMPORTANT: Read directions for proper use.
Sealed With Printed Neckband For Your Protection
1L (33.8 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 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:53942-163-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/13/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/13/2006 Labeler - Demoulas Super Markets, Inc. (007869647) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(53942-163) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(53942-163)