Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid
- NDC Code(s): 11673-482-86
- Packager: Target Corporation
- 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 March 7, 2022
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- Official Label (Printer Friendly)
- 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 twice daily after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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
- Inactive ingredients
- Questions or comments
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SPL UNCLASSIFIED SECTION
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate burshing may prevent it occurence.
*This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse
Distributed by Target Corporation
Minneapolis, MN 55403
Made in the U.S.A. with U.S. and foreign components
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principal display panel
SEALED WTIH PRINTED NECKBAND FOR YOUR PROTECTION
anticavity
alcohol-free fluoride mouth rinse
Compare to the active ingredient in Crest Advanced*
helps prevent cavities
helps make enamel stronger
helps clean the entire mouth
freshens breath
no alcohol burn
IMPORTANT: read directions for proper use
up & up
MINT FLAVOR
33.8 FL OZ (1 L)
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INGREDIENTS AND APPEARANCE
ALCOHOL-FREE ANTICAVITY
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-482 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) BENZOIC ACID (UNII: 8SKN0B0MIM) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-482-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/09/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/09/2012 Labeler - Target Corporation (006961700) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11673-482) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11673-482)