FDA.reportPublic FDA data

V34 Colour Corrector

Manufacturer
Nanchang Dental Bright Technology Co.,Ltd.
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:51

Label at a glance#

ProductV34 Colour Corrector
Active ingredientSODIUM PYROPHOSPHATE
Label structure13 sections

Dosage and administration

1. Apply 2 pumps to a soft bristle toothbrush. 2. Gently brush it a circular motion for 2 minutes. 3. Expel excess and rinse mouth after use, do not swallow.

Storage and handling

please keep in dry and cool place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrasodium Pyrophosphate

Purpose

OTC - PURPOSE SECTION

Teeth cleaning

Use

INDICATIONS & USAGE SECTION

Those who want to clean and whiten their teeth.

Warnings

WARNINGS SECTION

Product is not intended for use by children. Do not swallow. Do not use in eye area.

Do not use

OTC - DO NOT USE SECTION

Product is not intended for use by children.

When Using

OTC - WHEN USING SECTION

Do not swallow. Do not use in eye area.

Stop Use

OTC - STOP USE SECTION

If there is any discomfort, please stop using.

Ask Doctor

OTC - ASK DOCTOR SECTION

If there is any discomfort, please consult a dentist immediately

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of young children

Directions

DOSAGE & ADMINISTRATION SECTION

1. Apply 2 pumps to a soft bristle toothbrush.
2. Gently brush it a circular motion for 2 minutes.
3. Expel excess and rinse mouth after use, do not swallow.

Other information

STORAGE AND HANDLING SECTION

please keep in dry and cool place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin、Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Polysorbate 80、Cellulose Gum、Mentha Piperita(peppermint) oil 、Phenoxyethanol、Sucralose、Ethylhexylglycerin、CI17200/D&C Red No.33、CI 42090/FD&C Blue No.1

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83778-001-012025-01-30C16284748780-11030e365-4f2c-111a-e063-dadaa90a10e209008c6f-faa0-ccd4-e063-6294a90ad315
83778-001-012024-01-30C16284748780-11030e365-4f2c-111a-e063-dadaa90a10e209008c6f-faa0-ccd4-e063-6294a90ad315

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-001-01V34 Colour Corrector30 mL in 1 BOTTLECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83778-001V34 COLOUR CORRECTOR CREAM [NANCHANG DENTAL BRIGHT TECHNOLOGY CO.,LTD.]11 package rows20231106_09008c6f-faa0-ccd4-e063-6294a90ad315.zip

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
83778-00183778-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM PYROPHOSPHATEO352864B8ZACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
PEPPERMINT OILAV092KU4JHIACT
SUCRALOSE96K6UQ3ZD4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XYLITOLVCQ006KQ1EIACT
POLYSORBATE 806OZP39ZG8HIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
09008c6f-faa1-ccd4-e063-6294a90ad31509008c6f-faa0-ccd4-e063-6294a90ad3152023-10-31WarningsExact identifier
spl id: 09008c6f-faa1-ccd4-e063-6294a90ad315
spl set id: 09008c6f-faa0-ccd4-e063-6294a90ad315

Reported adverse events (FAERS/openFDA)#

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