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Colgate Sensitive Maximum Strength Whitening

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g, POTASSIUM NITRATE 50mg in 1g
Labeler: Mission Hills S.A. de C.V.
NDC Code: 65954-358

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.

Colgate®
Toothpaste for Sensitive Teeth
and Cavity Protection

Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antisensitivity

Anticavity

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities

Warnings

When using this product, do not use longer than 4 weeks unless recommended by a dentist or physician.

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 yearsconsult a dentist or a physician

Inactive ingredients

water, glycerin, hydrated silica, sorbitol, PEG-12, sodium lauryl sulfate, flavor, poloxamer 407, xanthan gum, cellulose gum, sodium saccharin, sodium hydroxide, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

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

www.colgatesensitive.com

PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

PRINCIPAL DISPLAY PANEL - 4.0 OZ carton

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

COLGATE  SENSITIVE MAXIMUM STRENGTH WHITENING
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-358
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN260 mg  in 1 g
WATER 
SORBITOL 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
POLOXAMER 407 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
XANTHAN GUM 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUE, WHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-358-601 TUBE in 1 CARTON
1170 g in 1 TUBE
2NDC:65954-358-021 TUBE in 1 CARTON
256 g in 1 TUBE
3NDC:65954-358-691 TUBE in 1 CARTON
3113 g in 1 TUBE
4NDC:65954-358-991 TUBE in 1 CARTON
451 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/26/2011
Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 12/2014
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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