Label: ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM- sodium fluoride rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-0015-7 - Packager: Greenbrier International, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 23, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
- remove cap
- use approximately one tablespoon and rinse vigorously 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
- supervise children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE (UNII: SE337SVY37) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) 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 DIBASIC DIHYDRATE (UNII: 94255I6E2T) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0015-7 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2010 Labeler - Greenbrier International, Inc. (610322518)