Label: COLGATE MAX FRESH COOL MINT- sodium fluoride gel, dentifrice
- NDC Code(s): 65954-564-81
- Packager: Mission Hills S.A de C.V
- 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.
Updated February 24, 2014
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Close
helps protect against cavitiesClose
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
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
sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, xanthan gum, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1Close
- SPL UNCLASSIFIED SECTION
New York, NY 10022
- PRINCIPAL DISPLAY PANEL - 130 g Bottle Label
Anticavity Fluoride Toothpaste
Lasts for Hours!
NET WT 4.6 OZ (130 g)
- INGREDIENTS AND APPEARANCE
COLGATE MAX FRESH COOL MINT
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-564 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) 665.38 mg in 1 g WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) XANTHAN GUM (UNII: TTV12P4NEE) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-564-81 130 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 04/06/2008 Labeler - Mission Hills S.A de C.V (812312122)