Colgate® Sensitive Multiprotection Fluoride Toothpaste 4.0 oz

Colgate Sensitive Multiprotection by

Drug Labeling and Warnings

Colgate Sensitive Multiprotection 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 MULTIPROTECTION- 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® Sensitive Multiprotection Fluoride Toothpaste 4.0 oz

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium fluoride 0.24% (0.15% w/v fluoride ion)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, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

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 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 physician

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, xanthan gum, titanium dioxide

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

MAXIMUM STRENGTH**

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

Sensitive
multiprotection

Clinically Proven
Sensitivity Relief

✓Whitens Teeth ✓Promotes Healthy Gums*
✓Removes Plaque* ✓Fights Tartar

NET WT 4.0 OZ (113 g)

Principal Display Panel - 113 g Tube Carton
COLGATE SENSITIVE MULTIPROTECTION 
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-046
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
HYDRATED SILICA (UNII: Y6O7T4G8P9) 16 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-046-691 in 1 CARTON01/12/2010
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-046-601 in 1 CARTON01/12/2010
2170 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 FINALpart35601/12/2010
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019