United Airlines Polaris Kit with Colgate

Manufacturer
Buzz Export Services Pty Ltd (Buzz Products)
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:18

Label at a glance#

ProductUnited Airlines Polaris Kit with Colgate
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call to-free 1-800-468-6502

Package Labeling:Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit03Kit03Kit04Kit04Kit05Kit05

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69491-041-01United Airlines Polaris Kit with Colgate1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-041UNITED AIRLINES POLARIS KIT WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD (BUZZ PRODUCTS)]2Current NDC, Legacy NDC, 1 package rows20231221_de4564a4-1012-baad-e053-2a95a90a11b7.zip
69491-060UNITED AIRLINES POLARIS KIT WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD (BUZZ PRODUCTS)]2Legacy NDC20231221_de4564a4-1012-baad-e053-2a95a90a11b7.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-04169491-041-01
69491-06069491-060-45

Ingredients#

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

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

Source Document#

Source XML

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
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
ndc (package): 69491-041-01
ndc (package): 69491-060-45
ndc (product): 69491-041
ndc11 (package): 69491006045
ndc11 (package): 69491004101
spl id: 0cfd9cc7-c30c-6671-e063-6294a90ac6a1
spl set id: de4564a4-1012-baad-e053-2a95a90a11b7

Reported adverse events (FAERS/openFDA)#

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