Label: ANTICAVITY- sodium fluoride rinse
- NDC Code(s): 30142-004-77
- Packager: Kroger Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Sodium fluoride 0.055% (0.02% w/v fluoride ion)Close
Use aids in the prevention of dental cavitiesClose
- Keep out of reach of children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediatelyClose
- adults and children 6 years of age and older: use once a day after brushing your teeth with toothpaste
- remove cap
- pour 10 mililiters (10 mL mark on inside of cap); do not fill above thr 10 mL mark
- vigorously swish 10 mililiters 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
- store at room temperature
- Inactive ingredients
Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, waterClose
- Adverse Reactions
Comments or Questions?
800-632-6900 or www. kroger.com
THE KORGER CO.
CINCINNATI, OH 45202Close
- Principal Display Panel
Sealed with printed neckband for your protection.
IMPORTANT: read directions for proper use
strong cavity protection
helps strengthen teeth
helps prevent cavities
16.0 FL OZ
- INGREDIENTS AND APPEARANCE
sodium fluoride rinse
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-004 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 10.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POLOXAMER 407 POLYSORBATE 80 PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SACCHARIN SODIUM SORBITOL WATER Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-004-77 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/18/2013 Labeler - Kroger Co (006999528) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(30142-004)