Optimax Anticavity Fluoride Cotton Candy

Manufacturer
WHITE GLO USA INC
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:55

Label at a glance#

ProductOptimax Anticavity Fluoride Cotton Candy
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

 Adults and children 2 years &  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 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

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and children 2 years & 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

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, Aqua, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No. 33.

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

LabelLabelLabel InnerLabel Inner

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73656-033-00Optimax Anticavity Fluoride Cotton Candy1 in 1 BOXPASTE11
73656-033-00Optimax Anticavity Fluoride Cotton Candy80 g in 1 TUBEPASTE801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73656-033OPTIMAX ANTICAVITY FLUORIDE COTTON CANDY (SODIUM MONOFLUOROPHOSPHATE) PASTE [WHITE GLO USA INC]1Current NDC, 2 package rows20250515_25f182cb-ad1e-4c13-bc79-1ec251754cf8.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
73656-03373656-033-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
ndc (package): 73656-033-00
ndc (product): 73656-033
ndc11 (package): 73656003300
spl id: 34f331d6-af77-69ea-e063-6394a90ae36e
spl set id: 25f182cb-ad1e-4c13-bc79-1ec251754cf8

Reported adverse events (FAERS/openFDA)#

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