Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 41163-004-77
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 8, 2024
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- Official Label (Printer Friendly)
- TEP
- Active ingredient
- Purpose
- Use
- Warnings
- Keep out of reach of children
-
Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigorously swish 10 millilitrs of rinse between your teeth for 1 minute then spit out
- do not swallow the rinse
- do not eat or drink for 30 miutes 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 year of age: consult a dentist or doctor
- Other information
- Inactive ingredient
- Disclaimer
- Adverse Reaction
- Principal panel display
-
INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-004 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 BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) EDETATE DISODIUM (UNII: 7FLD91C86K) 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 SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-004-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/17/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 08/17/2011 Labeler - United Natural Foods, Inc. dba UNFI (943556183) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(41163-004)
