Colgate® Toothpaste for Sensitive Teeth and Cavity Protection

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE SENSITIVE MAXIMUM STRENGTH WHITENING- sodium fluoride and potassium nitrate paste, dentifrice 
Mission Hills S.A. de C.V.

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.

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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

Principle Display Panel - 4.0 OZ Tube

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

Principle Display Panel - 4.0 OZ carton
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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 260 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE, WHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-358-601 in 1 CARTON07/26/2011
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-358-021 in 1 CARTON07/26/2011
256 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-358-691 in 1 CARTON07/26/2011
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-358-991 in 1 CARTON07/26/2011
451 g in 1 TUBE; Type 0: Not a Combination Product
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: 4/2019
 
Mission Hills S.A. de C.V.