Label: COLGATE MAX WHITE CRYSTAL MINT- sodium fluoride gel, dentifrice
- NDC Code(s): 65954-042-60, 65954-042-78, 65954-042-79, 65954-042-85
- Packager: Mission Hills S.A de C.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Sodium fluoride 0.24% (0.15% 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, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1, FD&C yellow no. 5Close
- SPL UNCLASSIFIED SECTION
New York, NY 10022
- PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
Anticavity Fluoride Toothpaste
Whitens to Help Teeth Stay Bright*
NET WT 6.0 OZ (170 g)
- INGREDIENTS AND APPEARANCE
COLGATE MAX WHITE CRYSTAL MINT
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-042 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL 564.38 mg in 1 g WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PYROPHOSPHATE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM POWDERED CELLULOSE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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:65954-042-60 1 in 1 CARTON 1 170 g in 1 TUBE 2 NDC:65954-042-78 1 in 1 CARTON 2 221 g in 1 TUBE 3 NDC:65954-042-85 1 in 1 CARTON 3 204 g in 1 TUBE 4 NDC:65954-042-79 1 in 1 CARTON 4 79 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 01/27/2009 Labeler - Mission Hills S.A de C.V (812312122)