Label: FLUORIDE MOUTH RINSE ANTICAVITY- sodium fluoride mouthwash
- NDC Code(s): 11673-213-44, 11673-213-77
- Packager: Target Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 7, 2023
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- Official Label (Printer Friendly)
- Tamper Evident Statment
- Active ingredient
- Purpose
- Use
- Warnings
- 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 toothpaste
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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
- Principal display panel
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INGREDIENTS AND APPEARANCE
FLUORIDE MOUTH RINSE ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-213 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:11673-213-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/17/2010 2 NDC:11673-213-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/17/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 08/17/2010 Labeler - Target Corp. (006961700) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11673-213) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11673-213)