Label: ANTICAVITY RINSE- sodium fluoride mouthwash
- NDC Code(s): 11822-4004-4
- Packager: Rite Aid
- 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 5, 2022
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
- Warning
- Keep out of reach of children.
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Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
- vigorously swish 10 milliliters 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
Sealed with printed neckband for your protection
Compare to Act Bubblegum Blowout Anticavity Kids Fluoride Rinse*
Free From
Alcohol Free
Kids Anticavity
Fluoride Rinse
Bubble Gum Flavor
strong cavity protection
helps strengthen teeth & prevent cavities
fresh & clean
Important: read directions for proper use.
18 FL OZ (532 mL)
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INGREDIENTS AND APPEARANCE
ANTICAVITY RINSE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength benzyl alcohol (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) poloxamer 407 (UNII: TUF2IVW3M2) polysorbate 80 (UNII: 6OZP39ZG8H) propylene glycol (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) sodium benzoate (UNII: OJ245FE5EU) sodium phosphate (UNII: SE337SVY37) saccharin (UNII: FST467XS7D) sorbitol (UNII: 506T60A25R) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-4004-4 532 mL in 1 PACKAGE; Type 0: Not a Combination Product 12/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/05/2022 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-4004) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-4004)