COLGATE TOTAL ZX PRO-SHIELD PLUS SENSITIVE- sodium monofluorophosphate, zinc citrate trihydrate and potassium nitrate paste, 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.

----------

Colgate® Total® Zx Pro-Shield™ Plus Sensitive

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium monofluorophosphate 1.14% (0.20% w/v fluoride ion)Anticavity
Zinc citrate trihydrate 2%Antigingivitis

Uses

  • aids in the prevention of cavities, plaque, and gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

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 under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Ask a dentist before use if you have

  • bleeding or redness lasting more than 2 weeks
  • pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

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 years of ageConsult a dentist or physician.

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PEG-12, tetrasodium pyrophosphate, PVM/MA copolymer, sodium lauryl sulfate, flavor, sodium saccharin, cellulose gum, sodium hydroxide, xanthan gum, polyethylene, mica, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10, FD&C blue no. 1 lake

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 215 g Tube Carton

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

New Active Ingredients
MINT GEL

Total® Zx

PRO-SHIELD™
PLUS SENSITIVITY

✓ SENSITIVITY
✓ CAVITIES
✓ ENAMEL
✓ PLAQUE
✓ GINGIVITIS
✓ TARTAR
✓ BREATH
✓ WHITENS

NET WT 7.6 OZ (215 g)
LONG-LASTING PROTECTION FOR TEETH, GUMS AND SENSITIVITY*

Principal Display Panel- 215 g Tube Carton
COLGATE TOTAL ZX PRO-SHIELD PLUS SENSITIVE 
sodium monofluorophosphate, zinc citrate trihydrate, and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-027
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion2 mg  in 1 g
Zinc Citrate Trihydrate (UNII: GNM26GAX7R) (Anhydrous Citric Acid - UNII:XF417D3PSL) Zinc Citrate Trihydrate20 mg  in 1 g
Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Butyl Ester Of Methyl Vinyl Ether/Maleic Anhydride Copolymer (125000 MW) (UNII: 389H2R62BD)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Xanthan Gum (UNII: TTV12P4NEE)  
High Density Polyethylene (UNII: UG00KM4WR7)  
Mica (UNII: V8A1AW0880)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
Aluminum Oxide (UNII: LMI26O6933)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-027-691 in 1 CARTON
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-027-661 in 1 CARTON
2164 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-027-761 in 1 CARTON
3215 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 finalpart35602/01/201309/01/2013
Labeler - Colgate-Palmolive (068693167)

Revised: 1/2016
Document Id: 6553bec1-d9c2-4365-b2c8-e9e4fa414407
Set id: f3ad2f77-e0f9-4e22-a4a0-c89755a0f011
Version: 2
Effective Time: 20160108
 
Colgate-Palmolive