WHITE GLO MICELLAR

Manufacturer
WHITE GLO USA INC | Suzhou Baozi Healthy Technology Co.,Ltd
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:56:08

Label at a glance#

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 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 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.

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

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, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, cocamidopropyl betaine, propylene glycol, FD&C Red 40

Questions or comments

OTC - QUESTIONS SECTION

For customer enquiries, please contact: customer.enquiry@whiteglo.com White Glo USA INC.25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

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 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

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
73656-003-00WHITE GLO MICELLAR1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73656-003WHITE GLO MICELLAR (SODIUM MONOFLUOROPHOSPHATE) KIT [WHITE GLO USA INC]5Current NDC, Legacy NDC, 1 package rows20250228_16be06ba-330d-46b8-ba4e-5d732642ee26.zip
73656-004WHITE GLO MICELLAR (SODIUM MONOFLUOROPHOSPHATE) KIT [WHITE GLO USA INC]5Unmatched20250228_16be06ba-330d-46b8-ba4e-5d732642ee26.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73656-00473656-004-00
73656-00373656-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
ndc (package): 73656-003-00
ndc (package): 73656-004-00
ndc (product): 73656-003
ndc11 (package): 73656000400
ndc11 (package): 73656000300
spl id: 2f18c530-ff7b-9217-e063-6294a90aea9c
spl set id: 16be06ba-330d-46b8-ba4e-5d732642ee26

Reported adverse events (FAERS/openFDA)#

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