FDA.reportPublic FDA data

UA Main Cabin Hawaii Premium 2020 w Colgate

Manufacturer
Buzz Products (HK) Co. Limited
Effective date
2020-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:56

Label at a glance#

ProductUA Main Cabin Hawaii Premium 2020 w Colgate
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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 toll-free 1-800-492-7378

Package Labeling: (69491-235-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKitKit2Kit2

Package Labeling: (69491-060-94)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70402-235-002022-01-28C16284748780-1d6a99b39-3951-a426-e053-dadaa90af4c2UA Main Cabin Hawaii Premium Kit 2020 w Colgate Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70402-235-00UA Main Cabin Hawaii Premium 2020 w Colgate1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060UA MAIN CABIN HAWAII PREMIUM 2020 W COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ PRODUCTS (HK) CO. LIMITED]1Current NDC, Legacy NDC20200313_9fe37663-4066-a787-e053-2995a90ac1a4.zip
70402-235UA MAIN CABIN HAWAII PREMIUM 2020 W COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ PRODUCTS (HK) CO. LIMITED]1Legacy NDC, 1 package rows20200313_9fe37663-4066-a787-e053-2995a90ac1a4.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70402-23570402-235-00
42555-06042555-060-94

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
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYL SALICYLATELAV5U5022YIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
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
9fe37663-4067-a787-e053-2995a90ac1a49fe37663-4066-a787-e053-2995a90ac1a42020-03-02WarningsExact identifier
spl id: 9fe37663-4067-a787-e053-2995a90ac1a4
spl set id: 9fe37663-4066-a787-e053-2995a90ac1a4

Reported adverse events (FAERS/openFDA)#

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