Whitening

Manufacturer
Guangzhou Baishili Trading Co., Ltd
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:01

Label at a glance#

ProductWhitening
Active ingredientHYDRATED SILICA, GLYCERIN, XANTHAN GUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Emphasize that the toothpaste uses mild whitening ingredients that do not damage tooth enamel, is suitable for daily use, and helps users easily achieve teeth whitening effects

WARNINGS SECTION

Warnings:

For external use only: Do not ingest the toothpaste. If swallowed, seek medical help immediately.

Avoid use on damaged or sensitive gums: If you have sensitive teeth, gums, or any oral health concerns, consult with a dentist before using this product.

Possible sensitivity: Some individuals may experience mild tooth or gum sensitivity with whitening products. Discontinue use if sensitivity persists or worsens, and consult a dentist if necessary.

Keep out of reach of children: This product is intended for adults and should be stored out of reach of children. Children under 12 years of age should only use this product with the guidance of a dentist.

Avoid contact with eyes: In case of accidental contact with eyes, rinse thoroughly with water. Seek medical attention if irritation continues.

Example: "For external use only. Do not swallow. Consult a dentist if you have sensitive teeth or gums. Discontinue use if sensitivity occurs. Keep out of reach of children and avoid contact with eyes."

INDICATIONS & USAGE SECTION

Indications:

This product is intended for individuals looking to remove surface stains and achieve a natural whitening effect.
Suitable for adults experiencing mild tooth discoloration caused by coffee, tea, red wine, or smoking.
Not recommended for individuals with sensitive teeth or gums. Please consult a dentist before use if you have dental concerns.

Usage:

Use twice daily, morning and night. Apply a pea-sized amount of toothpaste to your toothbrush.
Gently brush teeth for at least two minutes, ensuring the toothpaste covers all tooth surfaces.
Rinse thoroughly after brushing; avoid swallowing.
For optimal whitening results, continue use for at least two weeks, and limit consumption of stain-causing foods and drinks.

OTC - STOP USE SECTION

Stop Use:

If irritation or discomfort occurs: Discontinue use immediately if you experience persistent irritation, discomfort, or unusual sensitivity in teeth or gums.

If symptoms worsen: Stop using the product if symptoms such as pain, inflammation, or tooth sensitivity intensify. Consult a dentist before resuming use.

If allergic reaction develops: Discontinue use if you notice signs of an allergic reaction, such as redness, itching, or swelling in the mouth or on the gums.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Here’s how the KEEP OUT OF REACH OF CHILDREN section could be presented for a whitening toothpaste:

Keep Out of Reach of Children:

This product is intended for adult use only. Do not allow children to use without supervision or the guidance of a dentist.

In case of accidental ingestion by a child, seek immediate medical assistance or contact a Poison Control Center.

Example: "Keep out of reach of children. For adult use only. If swallowed by a child, get medical help or contact a Poison Control Center immediately."

DOSAGE & ADMINISTRATION SECTION

Here’s how the DOSAGE & ADMINISTRATION section for a whitening toothpaste could be structured:

Dosage & Administration:

Recommended Dosage: Use a pea-sized amount of toothpaste per brushing session.

Frequency of Use: Brush teeth twice daily, in the morning and at night, or as directed by a dentist.

Administration Instructions:

Apply a pea-sized amount of toothpaste to a toothbrush.
Brush teeth gently for at least two minutes, covering all tooth surfaces.
Rinse thoroughly after brushing and avoid swallowing the product.

Duration for Optimal Results: For best whitening results, use consistently for a minimum of two weeks. Consult a dentist if additional whitening is desired or if you plan to use for an extended period.

Example: "Apply a pea-sized amount and brush twice daily for two minutes, ensuring full coverage. Rinse thoroughly after use. For optimal whitening, continue use for at least two weeks."

INACTIVE INGREDIENT SECTION

LYSOZYME

SODIUM PHYTATE

SORBITOL

WATER

SACCHARIN SODIUM

SODIUM LAURYL SULFATE

DOSAGE & ADMINISTRATION SECTION

HYDRATED SILICA

XANTHAN GUM

GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC WHITENING TOOTHPASTEI 100g 20241101NDC WHITENING TOOTHPASTEI 100g 20241101

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
84727-051-012025-07-29C16284748780-13b156c62-2d0e-fb37-e063-e6dba90a4e0726bc06e3-cc87-c67e-e063-6394a90abb8e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84727-051-01Whitening100 g in 1 TUBEGEL, DENTIFRICE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84727-051WHITENING (YAYASHI WHITENING) GEL, DENTIFRICE [GUANGZHOU BAISHILI TRADING CO., LTD]11 package rows20241115_26bc06e3-cc87-c67e-e063-6394a90abb8e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84727-05184727-051-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
26bc06e3-cc88-c67e-e063-6394a90abb8e26bc06e3-cc87-c67e-e063-6394a90abb8e2024-11-12WarningsExact identifier
spl id: 26bc06e3-cc88-c67e-e063-6394a90abb8e
spl set id: 26bc06e3-cc87-c67e-e063-6394a90abb8e

Reported adverse events (FAERS/openFDA)#

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