Professional whitening tooth

Manufacturer
Guangzhou City Caiye Cosmetics CO., Ltd
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:48:31

Label at a glance#

ProductProfessional whitening tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Dosage and administration

Adults and children 2 years of age & older: Brush teth 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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity tothpaste

Use

INDICATIONS & USAGE SECTION

Use helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is
acidentally sallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use on open skin wounds

OTC - WHEN USING SECTION

Please keep away from your eyes when using this product

OTC - STOP USE SECTION

If in contact with the eyes, rinse thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age & older: Brush teth 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

STORAGE AND HANDLING 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

Calium Carbonate, Water, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl
Sulfate, Aawour, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Cellulose
Gum, Hydroyethylollulose, Benzyl Alcohol, Tetrasodium Pyrophosphate, Rosa
Canina (Rose hip) Fruit 0il.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82168-004-012026-01-29C16284748780-149896155-a96e-586f-e063-e6dba90add9082168-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82168-004-01Professional whitening tooth100 g in 1 BOXPASTE1002

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
82168-00482168-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
ndc (package): 82168-004-01
ndc (product): 82168-004
ndc11 (package): 82168000401
spl id: 4c16da29-b13d-52ff-e063-6394a90aedda
spl set id: 291eba71-14da-fac3-e063-6294a90aa3cc

Reported adverse events (FAERS/openFDA)#

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