FDA.reportPublic FDA data

Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

Manufacturer
Colgate Oral Pharmaceuticals, Inc. | Colgate-Palmolive Company
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:07:09

Label at a glance#

ProductColgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

adults and children 6 years of age and older use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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 nece...

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 0.04% (0.02% 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 once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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
  • ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

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 - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE*

Colgate®

Phos•Flur®

Ortho Defense®

Anticavity Fluoride Rinse
Sodium Fluoride Acidulated Phosphate Solution

IDEAL PROTECTION
WHILE WEARING BRACES

  1. ORTHODONTIST RECOMMENDED
  2. HELPS STRENGTHEN ENAMEL
  3. HELPS PREVENT CAVITIES

GUSHING GRAPE

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

ADA
Accepted
American
Dental
Association ®

P9910320

Principal Display Panel - 500 mL Bottle Label
Principal Display Panel - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinsePSN8
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN8
1721964sodium fluoride 0.2 MG/ML Mouthwash [Colgate]SBD8
313029sodium fluoride 0.2 MG/ML MouthwashSCD8
1721964Colgate 0.02 % (0.01 % fluoride ion) Oral RinseSY8
1721964Colgate 0.2 MG/ML MouthwashSY8
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY8
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0034-46Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride500 mL in 1 BOTTLERINSE5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0034COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE (SODIUM FLUORIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20240113_9a976ac8-d966-4d94-93da-45652f2d2481.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0126-00340126-0034-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM PHOSPHATESE337SVY37IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLYSORBATE 207T1F30V5YHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML · Source PDF

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
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
ndc (package): 0126-0034-46
ndc (product): 0126-0034
ndc11 (package): 00126003446
spl id: 0c0515c6-25cb-46b6-ada6-79f8aeb97a28
spl set id: 9a976ac8-d966-4d94-93da-45652f2d2481

Reported adverse events (FAERS/openFDA)#

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