Label: FRESHENUP FLUORIDE DOUBLE MINT- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 52553-049-02 - Packager: U. S. Nonwovens Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 14, 2019
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- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years and older brush teeth thoroughly after meals or at least 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 - Inactive ingredients
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
FRESHENUP FLUORIDE DOUBLE MINT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52553-049 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) XANTHAN GUM (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52553-049-02 1 in 1 CARTON 08/14/2019 1 99.2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/14/2019 Labeler - U. S. Nonwovens Corp (847061520) Registrant - U. S. Nonwovens Corp (847061520) Establishment Name Address ID/FEI Business Operations Dabur India Limited 650599231 manufacture(52553-049)