DELTA COMFORT PLUS 2019 AMENITY With Colgate Cavity Protection

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:47

Label at a glance#

ProductDELTA COMFORT PLUS 2019 AMENITY With Colgate Cavity Protection
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 apea 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 apea 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

1-800-492-7378

DELTA COMFORT PLUS 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste (69491-210-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

COLGATE ANTICAVITY 5g (42555-060-94)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelPastePasteBrushBrushEar plugsEar plugs

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-210-002023-01-30C16284748780-1f386c649-ee0c-0266-e053-dadaa90a7c1aDELTA COMFORT PLUS 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-060DELTA COMFORT PLUS 2019 AMENITY WITH COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Current NDC, Legacy NDC20211228_eb14c303-df61-4b07-ad46-8021447aa9fc.zip
69491-210DELTA COMFORT PLUS 2019 AMENITY WITH COLGATE CAVITY PROTECTION (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY., LTD.]3Legacy NDC20211228_eb14c303-df61-4b07-ad46-8021447aa9fc.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
69491-21069491-210-00
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.

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
4d26f358-a654-e5ba-e063-6294a90a66f1eb14c303-df61-4b07-ad46-8021447aa9fc2026-03-16WarningsExact identifier
spl set id: eb14c303-df61-4b07-ad46-8021447aa9fc
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.