Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 37808-119-86
- Packager: H E Butt
- 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 April 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- active ingredients
- 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
- guarantee
- Adverse reactions section
- Disclaimer
-
principal display panel
Compare to Listerine Total Care Zero Alcohol
H-E-B
Alcohol Free
ANTICAVITY
MOUTHWASH
SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION
- Helps strengthen teeth to fight cavities
- Restored enamel
- Kills bad breath germs
- Cleans the entire mouth**
- Alcohol Free
- Fresh Mint
IMPORTANT: read directions for proper use
33.8 FL OZ (1.05 QT) 1 L
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-119 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) 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) menthol (UNII: L7T10EIP3A) 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:37808-119-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 04/20/2021 Labeler - H E Butt (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37808-119) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37808-119)