Label: COLGATE RE RENEW- sodium fluoride paste, dentifrice
- NDC Code(s): 35000-744-59
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 21, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 107 g Tube Label
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INGREDIENTS AND APPEARANCE
COLGATE RE RENEW
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-744 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) PHOSPHORIC ACID (UNII: E4GA8884NN) XANTHAN GUM (UNII: TTV12P4NEE) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) 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:35000-744-59 107 g in 1 TUBE; Type 0: Not a Combination Product 08/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 08/07/2021 Labeler - Colgate-Palmolive Company (001344381)