FDA.reportPublic FDA data

DELTA RON 2019 AMENITY With Colgate Cavity Protection

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:20:42

Label at a glance#

ProductDELTA RON 2019 AMENITY With Colgate Cavity Protection
Active ingredientSODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
Label structure15 sections

Indications and uses

Reduces Underarm Wetness 48 Hour Protection

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

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum Zirconium Tetrachlorohydrex GLY (15.2%)

Purpose

OTC - PURPOSE SECTION

anti-perspirant

Uses

INDICATIONS & USAGE SECTION

  • Reduces Underarm Wetness
  • 48 Hour Protection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on broken skin

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have kidney disease.

Stop use

OTC - STOP USE SECTION

if rash or irritation occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to underarms only

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, PEG-8, Fragrance (Parfum), Dimethicone, Silica, Polyethylene, Helianthus Annuus (Sunflower) Seed Oil, Steareth-100, BHT, Hydroxyethyl Urea

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-761-3683

DELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste (69491-215-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kit4Kit4

COLGATE ANTICAVITY 10g (42555-060-45)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2Tube4Tube4Brush2Brush2

DOVE ADVANCED CARE COOL ESSENTIALS ANTIPERSPIRANT AND DEODORANT 14 g (64942-1343-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4Label5Label5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69491-215-002023-03-03C16284748780-1f386c649-d5df-0266-e053-dadaa90a7c1aDELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste
69491-215-002023-01-30C16284748780-1f386c649-d5df-0266-e053-dadaa90a7c1aDELTA RON KIT 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-21569491-215-00
42555-06042555-060-45
64942-134364942-1343-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
CYCLOMETHICONE 50THT5PCI0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PPG-14 BUTYL ETHERR199TJT95TIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SUNFLOWER OIL3W1JG795YIIACT
STEARETH-1004OH5W9UM87IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY8O386558JEACTIB

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4d2683d6-52a9-f088-e063-6294a90aa9398d9d22bc-b620-4045-8b76-29b71e727a392026-03-16WarningsExact identifier
spl set id: 8d9d22bc-b620-4045-8b76-29b71e727a39
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
ndc (package): 42555-060-45
ndc (product): 42555-060
ndc11 (package): 42555006045
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045

Reported adverse events (FAERS/openFDA)#

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