Colgate Kids Halloween Wicked Watermelon

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 2.4mg in 1g
Labeler: Mission Hills S.A. de C.V.
NDC Code: 65954-504

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.

GLOW in the DARK
Colgate®
Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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.

Directions
adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

sorbitol, water, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, flavor, xanthan gum, FD&C blue no. 1, FD&C yellow no. 5

Questions?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 130g Bottle Label

GLOW in the DARK

Colgate®

Clinically Proven Cavity and Enamel Protection
Fluoride Toothpaste

wicked
watermelon
flavor

NET WT 4.6 OZ (130g) LIQUID GEL

COLGATE KIDS   HALLOWEEN WICKED WATERMELON
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-504
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL646.15 mg  in 1 g
GLYCERIN129.99 mg  in 1 g
HYDRATED SILICA117.99 mg  in 1 g
POLYETHYLENE GLYCOL 60013.99 mg  in 1 g
SODIUM LAURYL SULFATE17.24 mg  in 1 g
COCAMIDOPROPYL BETAINE12.5 mg  in 1 g
SODIUM PYROPHOSPHATE5 mg  in 1 g
SACCHARIN SODIUM3.15 mg  in 1 g
XANTHAN GUM2.2 mg  in 1 g
FD&C BLUE NO. 10.018 mg  in 1 g
FD&C YELLOW NO. 50.013 mg  in 1 g
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorWATERMELONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-504-81130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/26/2011
Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 07/2011
 
Mission Hills S.A. de C.V.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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