Label: IDODENT FLOURIDE MINT- fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-181-18 - Packager: United Exchange Corp.
- 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 November 24, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
Adults and children 2 years and older Brush Teeth thoroughly after meals, twice a day, or use as directed by a dentist or physician. Children under 6 years To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established. Children under 2 years Ask a dentist or physician. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IDODENT FLOURIDE MINT
fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-181 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM SILICATE (UNII: IJF18F77L3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-181-18 1 in 1 CARTON 12/21/2016 10/13/2021 1 181 g in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 10/23/2014 Labeler - United Exchange Corp. (840130579)