Label: COLGATE 2IN1 ICY BLAST- sodium fluoride gel, dentifrice
- NDC Code(s): 65954-355-81
- 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% (0.14% w/v fluoride ion)Close
aids in the prevention of cavitiesClose
Keep out of the 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, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, mica, titanium dioxide, D&C red no. 33 FD&C blue no. 1Close
Call toll-free 1-800-468-6502Close
- SPL UNCLASSIFIED SECTION
New York, NY 10022
- PRINCIPAL DISPLAY PANEL - 130 g Bottle Label
2 in 1
Cleans Teeth & Freshens Breath
Icy Blast ®
NET WT 4.6 OZ (130 g)
- INGREDIENTS AND APPEARANCE
COLGATE 2IN1 ICY BLAST
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-355 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 331.2 mg in 1 g WATER GLYCERIN HYDRATED SILICA SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SODIUM PYROPHOSPHATE SACCHARIN SODIUM MICA TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM XANTHAN GUM D&C RED NO. 33 FD&C BLUE NO. 1 Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-355-81 130 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 07/26/2011 Labeler - Mission Hills S.A de C.V (812312122)