Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 11822-0213-4
- 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 May 24, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Use
-
Warning
for this product
Keep out of reach of children.
If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
- adults and children 6 years of age and older: use once a day for 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 milliliter 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 display panel
Sealed with printed neckband for your protection
IMPORTANT: red directions for proper use.
Compare to the active ingredient of Act Anticavity Fluoride Mouthwash*
ANTICAVITY FLUORIDE WOUTHWASH
MINT
helps prevent cavities
HELPSstrengthens teeth
alcohol free
ADA Accepted
American Dental Association
Helps prevent cavities
18 FL OZ (532 mL)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0213 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) menthol (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE (UNII: SE337SVY37) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZYL ALCOHOL (UNII: LKG8494WBH) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0213-4 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/25/2005 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-0213) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-0213)