FDA.reportPublic FDA data

AquaWhite Red Gel Cavity FightingTooth

Manufacturer
JHS SVENDGAARD LABORATORIES LIMITED
Effective date
2018-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:10

Label at a glance#

ProductAquaWhite Red Gel Cavity FightingTooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sodium Monofluorophosphate 0.76%

OTC - PURPOSE SECTION

Purpose:

Anticavity

INDICATIONS & USAGE SECTION

Uses:

Helps protect  against cavities

WARNINGS SECTION

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Adults and children 2 years and older:
  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow
  • Children under 6 Years of Age
  • To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist or physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Red 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
72025-003-012020-01-31C16284748780-19d75b9d0-68ec-f424-e053-dadaa90a57ce4e3d4f5f-9f96-44d5-85f7-25c44293b353
72025-003-022020-01-31C16284748780-19d75b9d0-68ec-f424-e053-dadaa90a57ce4e3d4f5f-9f96-44d5-85f7-25c44293b353

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72025-003-01AquaWhite Red Gel Cavity FightingTooth80 g in 1 TUBEPASTE, DENTIFRICE801
72025-003-02AquaWhite Red Gel Cavity FightingTooth150 g in 1 TUBEPASTE, DENTIFRICE1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72025-003AQUAWHITE RED GEL CAVITY FIGHTINGTOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [JHS SVENDGAARD LABORATORIES LIMITED]1Legacy NDC, 2 package rows20180119_4e3d4f5f-9f96-44d5-85f7-25c44293b353.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72025-00372025-003-01, 72025-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XYLITOLVCQ006KQ1EIACT
SODIUM PHOSPHATESE337SVY37IACT
FD&C RED NO. 40WZB9127XOAIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62e88bbf-b2c1-50fa-e053-2991aa0a70e24e3d4f5f-9f96-44d5-85f7-25c44293b3532018-01-16WarningsExact identifier
spl id: 62e88bbf-b2c1-50fa-e053-2991aa0a70e2
spl set id: 4e3d4f5f-9f96-44d5-85f7-25c44293b353

Reported adverse events (FAERS/openFDA)#

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