FDA.reportPublic FDA data

Colgate Total Lasting White Polar Freshmint

Manufacturer
Colgate-Palmolive Company
Effective date
2015-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:46

Label at a glance#

ProductColgate Total Lasting White Polar Freshmint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of u...

Storage and handling

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, propylene glycol, sorbitol, sodium acrylates/methacryloylethyl phosphate copolymer, phosphoric acid, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, sodiumsaccharin, disodiumphosphate, potassiumsorbate, sodiumlauryl sulfate, sucralose

Other Information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

Total®

LASTING WHITE™

Strengthens Teeth &
Helps Protect Against Stains

  • Re-mineralizes & strengthens enamel
  • Helps prevent cavities
  • Fights tartar
  • Freshens breath
  • No burn of alcohol

POLAR FRESHMINT

IMPORTANT:
Read directions
for proper use

8.4 FL OZ
(250 mL)

P9895507

Principal Display Panel - 250 mL Bottle Label
Principal Display Panel - 250 mL Bottle Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)INACTIVE INGREDIENT389H2R62BD1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LEVOMENTHOLINACTIVE INGREDIENTBZ1R15MTK71
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POTASSIUM PYROPHOSPHATEINACTIVE INGREDIENTB9W4019H5G1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-72435000-724-84, 35000-724-16, 35000-724-33, 35000-724-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)389H2R62BDIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
POLYSORBATE 207T1F30V5YHIACT
PHOSPHORIC ACIDE4GA8884NNIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 376 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / ORAL19 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAVENOUS1294 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM PYROPHOSPHATESODIUM PYROPHOSPHATEO352864B8ZPASTE, DENTIFRICE / DENTAL1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHAEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / RECTAL46.18 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6748403-43db-4f66-8ae3-5c5e2565e18b3d8e4d17-8bfb-46c5-a564-7bce4f9932e92015-12-02WarningsExact identifier
spl id: d6748403-43db-4f66-8ae3-5c5e2565e18b
spl set id: 3d8e4d17-8bfb-46c5-a564-7bce4f9932e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.