Optimax Purple Anticavity Fluoride

Manufacturer
WHITE GLO USA INC
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:17

Label at a glance#

ProductOptimax Purple 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 monofluorophosphate 0.76% (0.1% W/W 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 accidentally 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 86° F, 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, Aroma, Cellulose Gum, Mentholum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No.33, FD&C Blue No.1.

Questions or comments

OTC - QUESTIONS SECTION

For customer enquiries, please contact: hello@optimax.today www.optimax.today

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

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
73656-034-00Optimax Purple Anticavity Fluoride1 in 1 KITKIT11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73656-03473656-034-00
73656-03573656-035-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
ndc (package): 73656-034-00
ndc (package): 73656-035-00
ndc (product): 73656-034
ndc11 (package): 73656003400
ndc11 (package): 73656003500
spl id: 3dd7ebc9-b4c9-92b0-e063-6394a90a068c
spl set id: 8264e849-a6b3-4953-a85b-da9d4e7f5a70

Reported adverse events (FAERS/openFDA)#

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