COLGATE ENAMEL HEALTH MINERAL REPAIR- potassium nitrate and sodium fluoride paste, dentifrice 
Colgate-Palmolive Company

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™ Mineral Repair

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 older: Apply 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 years: Consult a dentist or physician.

Inactive ingredients

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

Questions?

1-800-468-6502
www.colgate.com

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

Colgate®

Anticavity & Antisensitivity Toothpaste

ENAMEL
HEALTH™

MINERAL
REPAIR

HELPS REPAIR
WEAKENED ENAMEL
WITH VITAL MINERALS

  • ENAMEL EROSION
  • SENSITIVITY
  • WHITENS
  • CAVITIES
  • FRESHENS

MINT BURST
gel

NET WT 4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Label
COLGATE ENAMEL HEALTH MINERAL REPAIR 
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-209
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
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:35000-209-691 in 1 CARTON10/12/201512/31/2021
1113 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 FINALpart35610/12/201512/31/2021
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-209)

Revised: 12/2019
Document Id: 74288317-51eb-48f5-b189-ec4007a220f4
Set id: 689d6a77-0608-411c-860b-8b2726be3438
Version: 8
Effective Time: 20191209
 
Colgate-Palmolive Company