Label: COLGATE MAX CLEAN SPEARMINT BLAST- sodium fluoride gel, dentifrice
- NDC Code(s): 35000-931-60, 35000-931-85
- 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 December 5, 2019
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- 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Tube Label
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INGREDIENTS AND APPEARANCE
COLGATE MAX CLEAN SPEARMINT BLAST
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-931 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 24 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) 347 mg in 1 g WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SACCHARIN SODIUM (UNII: SB8ZUX40TY) 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:35000-931-85 1 in 1 CARTON 08/01/2011 1 204 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:35000-931-60 1 in 1 CARTON 08/01/2011 2 170 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 08/01/2011 Labeler - Colgate-Palmolive Company (001344381) Establishment Name Address ID/FEI Business Operations Colgate-Palmolive 785047999 MANUFACTURE(35000-931)