Label: COLGATE MAX CLEAN SPEARMINT BLAST- sodium fluoride gel, dentifrice
- NDC Code(s): 65954-382-60, 65954-382-85
- 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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- 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
water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5Close
- SPL UNCLASSIFIED SECTION
New York, NY 10022
- PRINCIPAL DISPLAY PANEL - 170 g Tube Label
Anticavity Fluoride Toothpaste
30% More Foam*
Cleans Tough to Reach Spaces
NET WT 6.0 OZ (170 g)
- INGREDIENTS AND APPEARANCE
COLGATE MAX CLEAN SPEARMINT BLAST
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-382 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 347 mg in 1 g WATER HYDRATED SILICA POLYETHYLENE GLYCOL 600 POLOXAMER 407 SODIUM LAURYL SULFATE XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM PYROPHOSPHATE MICA TITANIUM DIOXIDE FERRIC OXIDE RED POWDERED CELLULOSE SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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:65954-382-85 1 in 1 CARTON 1 204 g in 1 TUBE 2 NDC:65954-382-60 1 in 1 CARTON 2 170 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 08/01/2011 Labeler - Mission Hills S.A de C.V (812312122)