Label: COLGATE MAX FRESH ADVANCED WHITENING- sodium fluoride gel, dentifrice
- NDC Code(s): 35000-899-34, 35000-899-60, 35000-899-95
- 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 14, 2021
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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 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 - 170 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE MAX FRESH ADVANCED WHITENING
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-899 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) 564.38 mg in 1 g WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POWDERED CELLULOSE (UNII: SMD1X3XO9M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color BLUE (LIGHT BLUE WITH WHITE FILM) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-899-60 1 in 1 CARTON 10/16/2021 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-899-95 1 in 1 CARTON 10/16/2021 2 178 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-899-34 2 in 1 CARTON 10/16/2021 3 170 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 10/16/2021 Labeler - Colgate-Palmolive Company (001344381)