Colgate® Tartar Control Whitening Crisp Mint® Paste Fluoride Toothpaste

Colgate by

Drug Labeling and Warnings

Colgate 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  TARTAR CONTROL WHITENING CRISP MINT- sodium fluoride 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® Tartar Control Whitening Crisp Mint® Paste Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.16% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of 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.

Directions

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

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

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Colgate®
Anticavity
Fluoride Toothpaste

NET WT 4.0 OZ (113 g)

Tartar
Protection
WHITENING

Fights Tartar and
Whitens Teeth

CRISP MINT®
paste

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
COLGATE   TARTAR CONTROL WHITENING CRISP MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-162
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
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R) 405.57 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-162-791 in 1 CARTON01/08/2011
179 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-162-461 in 1 CARTON01/08/2011
2130 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-162-641 in 1 CARTON01/08/2011
3181 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-162-821 in 1 CARTON01/08/2011
4232 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 65954-162-601 in 1 CARTON01/08/2011
5170 g in 1 TUBE; Type 0: Not a Combination Product
6NDC: 65954-162-691 in 1 CARTON01/08/2011
6113 g in 1 TUBE; Type 0: Not a Combination Product
7NDC: 65954-162-581 in 1 CARTON01/08/2011
770 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/08/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019
 
Mission Hills S.A de C.V