Delta Sky Club

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 22:20:40

Label at a glance#

ProductDelta Sky Club
Active ingredientSODIUM FLUORIDE
Label structure7 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'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, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour,) cellulose gum, tetrasodium pyrophosphate, sodium saccharinm limonene

Questions or comments?

OTC - QUESTIONS SECTION

Call to-free 1-800-468-6502

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2Tube2Tube2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-101-002024-01-30C16284748780-11030e365-0f76-111a-e063-dadaa90a10e2Delta Sky Club Dental Kit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-060DELTA SKY CLUB (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD]3Legacy NDC20211228_6e20c627-b72a-0bdb-e053-2a91aa0ae5db.zip
69491-101DELTA SKY CLUB (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY LTD]3Legacy NDC20211228_6e20c627-b72a-0bdb-e053-2a91aa0ae5db.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
69491-10169491-101-00
69491-06069491-060-94

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0cfd238f-51e2-9183-e063-6394a90ad7896e20c627-b72a-0bdb-e053-2a91aa0ae5db2024-02-12WarningsExact identifier
spl set id: 6e20c627-b72a-0bdb-e053-2a91aa0ae5db

Reported adverse events (FAERS/openFDA)#

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