Label: COLGATE MAX FRESH CLEAN MINT- sodium fluoride gel, dentifrice
- NDC Code(s): 35000-902-60, 35000-902-63, 35000-902-78
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated November 27, 2019
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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 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 CLEAN MINT
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-902 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) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color GREEN Score Shape Size Flavor SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-902-60 1 in 1 CARTON 08/01/2011 1 170 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-902-78 1 in 1 CARTON 08/01/2011 2 221 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-902-63 1 in 1 CARTON 03/28/2022 3 178 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 08/01/2011 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Mission Hills, S.A. de C.V. 812312122 ANALYSIS(35000-902) , MANUFACTURE(35000-902) , PACK(35000-902) , LABEL(35000-902)