Label: COLGATE ULTRA PROTECT- sodium fluoride paste, dentifrice
- NDC Code(s): 35000-993-98
- 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 October 20, 2020
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- Official Label (Printer Friendly)
- 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 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 - 62 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE ULTRA PROTECT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-993 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 SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) 220 mg in 1 g SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-993-98 1 in 1 CARTON 10/16/2020 1 62 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 FINAL part355 10/16/2020 Labeler - Colgate-Palmolive Company (001344381)