COLGATE ENAMEL HEALTH SENSITIVITY RELIEF- potassium nitrate and sodium fluoride gel, dentifrice 
Colgate-Palmolive

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® Enamel Health Sensitivity Relief

Drug Facts

Active ingredientPurpose
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 2 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, sorbitol, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, microcrystalline cellulose, zinc phosphate, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Toothpaste for Sensitive Teeth

ENAMEL
HEALTH

SENSITIVITY RELIEF

STRENGTHEN & REPLENISH

STRENGTHENS ENAMEL 4X BETTER
HELPS REPLENISH NATURAL CALCIUM

NET WT 6.0 OZ (170 g)
FRESH MINT gel

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE ENAMEL HEALTH SENSITIVITY RELIEF 
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-206
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ZINC PHOSPHATE (UNII: 1E2MCT2M62)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-206-201 in 1 CARTON06/30/201409/30/2023
124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-206-691 in 1 CARTON06/30/201409/30/2023
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-206-261 in 1 CARTON06/30/201409/30/2023
3155 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-206-601 in 1 CARTON11/30/201709/30/2023
4170 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 FINALpart35606/30/201409/30/2023
Labeler - Colgate-Palmolive (001344381)

Revised: 10/2019
 
Colgate-Palmolive