FDA.reportPublic FDA data

United Airlines Polaris Kit

Manufacturer
Buzz Products Inc
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:34:00

Label at a glance#

ProductUnited Airlines Polaris Kit
Active ingredientSODIUM MONOFLUOROPHOSPHATE, ALCOHOL
Label structure15 sections

Indications and uses

To help reduce bacteria on the skin.

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's 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's 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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • To help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not dispose of wipes in flush toilets. 
  • Keep away from fire or flame.

Flammable

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Appyl to hands or surface.
  • No rinsing required.
  • Discard after use.

Other Information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycerin, Polyquaternium-37, Melaleuca Alternifolia Leaf Oil.

Package Labeling:69491-036-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKitKit2Kit2

Package Labeling:42555-060-94

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

Package Labeling:69491-035-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-03669491-036-01
42555-06042555-060-94
69491-03569491-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYL SALICYLATELAV5U5022YIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
ALCOHOL3K9958V90MACTIB

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4d268ed7-ad21-1e14-e063-6294a90a3c1ad31dd3b7-e669-6506-e053-2995a90a03d02026-03-16WarningsExact identifier
spl set id: d31dd3b7-e669-6506-e053-2995a90a03d0
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
ndc (package): 42555-060-94
ndc (product): 42555-060
ndc11 (package): 42555006094
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
ndc (package): 42555-060-94
ndc11 (package): 42555006094

Reported adverse events (FAERS/openFDA)#

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