COLGATE TOTAL FRESH MINT STRIPE- sodium fluoride and triclosan paste, dentifrice 
Colgate-Palmolive Company

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Colgate® Total® Fresh Mint Stripe Gel

Drug Facts

Active ingredientsPurpose
Sodium Fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
Triclosan 0.30%Antigingivitis

Uses

aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Warnings

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

supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

Water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADA
Accepted
American
Dental
Association ®

FRESH MINT STRIPE

NET WT 6.0 OZ (170 g)
LONG LASTING FRESH BREATH

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

Gel

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE TOTAL FRESH MINT STRIPE 
sodium fluoride and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-161
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
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-161-601 in 1 CARTON08/05/201312/31/2021
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-161-781 in 1 CARTON08/05/201312/31/2021
2221 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-161-092 in 1 CARTON04/18/201612/31/2021
3170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023108/05/201312/31/2021
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-161)

Revised: 12/2019
Document Id: 5a8e437e-600f-4794-a5e6-bc15b63d7061
Set id: eeae522f-645c-4a16-8514-37907da323df
Version: 10
Effective Time: 20191209
 
Colgate-Palmolive Company