Optimax Professional Whitening Anticavity Fluoride

Manufacturer
WHITE GLO USA INC
Effective date
2025-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:20:33

Label at a glance#

ProductOptimax Professional Whitening Anticavity Fluoride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

 Adults and children 2 years of age & older:  Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.  Children under 6 years of age:  Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monoflurorophosphate 0.76% (0.1% W/V Fluoride ion).

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and children 2 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store in a cool place, below 86ºF, away from heat
  • Do not use if quality seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl SuIfate, Flavor, Cellulose Gum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate.

Questions or comments

OTC - QUESTIONS SECTION

For customer enquiries, please contact: hello@optimax.today
White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell,
California, 95008. www.optimax.today

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package02Outer Package02Inner Package2Inner Package2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73656-038-00Optimax Professional Whitening Anticavity Fluoride1 in 1 KITKIT11

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
73656-03873656-038-00
73656-03773656-037-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact identifier
ndc (package): 73656-037-00
ndc11 (package): 73656003700
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact identifier
ndc (package): 73656-037-00
ndc (package): 73656-038-00
ndc (product): 73656-038
ndc11 (package): 73656003700
ndc11 (package): 73656003800
spl id: 3f187626-b3c5-6648-e063-6294a90a7836
spl set id: c1bbdd36-53fb-43a3-ba20-afbeb6359d31

Reported adverse events (FAERS/openFDA)#

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