Label: KIDS FLOURIDE RINSE- sodium fluoride rinse
- NDC Code(s): 67091-104-44
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 29, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
- remove cap
- pour 10 millilters (10 mL mark on inside of cap); do not fill above 10 mL mark
- vigourously swish 10 milliliters 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
- Questions?
- SPL UNCLASSIFIED SECTION
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principal display panel
SEALED WITH PRINTED NECKAND FOR YOUR PROTECTION
Compare to the active indredient in ACT Anticavity Kids Flouride Rinse
WinCo FOODS
ANTICAVITY Fluoride Rinse
Strong Cavity Protection
Alcohol Free
Helps Strengthen Teeth
ADA
Accepted
American
Dental
Association
Bubble Gum Flavor
18 FL OZ (532 mL)
IMPORTANT READ DIRECTIONS FOR PROPER USE
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INGREDIENTS AND APPEARANCE
KIDS FLOURIDE RINSE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-104 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:67091-104-44 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 02/09/2011 Labeler - WinCo Foods, LLC (056098817) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(67091-104)