FDA.reportPublic FDA data

Neateeth Teeth Whitening Strips

Manufacturer
Nanchang Dental Bright Technology Co.,Ltd.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:05:21

Label at a glance#

ProductNeateeth Teeth Whitening Strips
Active ingredientPHTHALIMIDOPEROXYCAPROIC ACID
Label structure12 sections

Dosage and administration

Remove strips frombacker，apply upper strip to top teeth, and repeat with bottom teeth.Leave for 30 minutes,avoid eating or drinking.Remove and discard strips,rinse away any existing gel and admire.

Storage and handling

Please keep in dry and cool place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phthalimidoperoxycaproic Acid 12%

Purpose

OTC - PURPOSE SECTION

Teeth Whitening

Use

INDICATIONS & USAGE SECTION

Once a day, one strip at a time

Warnings

WARNINGS SECTION

1.Not intended for children under 16.

2.Do not swallow strip.

3.If the strip comes into contact with skin, it may cause temporary skin irritation.

Do not use

OTC - DO NOT USE SECTION

Not suitable for people who have ulcers, exposed gums or after oral surgery.

When Using

OTC - WHEN USING SECTION

Avoid contact of strips with eyes or skin.

Stop Use

OTC - STOP USE SECTION

If there is any discomfort, please stop using and 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

Remove strips frombacker，apply upper strip to top teeth, and repeat with bottom teeth.Leave for 30 minutes,avoid eating or drinking.Remove and discard strips,rinse away any existing gel and admire.

Other information

STORAGE AND HANDLING SECTION

Please keep in dry and cool place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aroma,Water(Aqua),Glycerin,Hydroxypropyl Cellulose,Potassium Citrate,PVP K30,PVP K90,Xylitol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001001002002003003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83778-006-012025-01-30C16284748780-12cef2736-883b-d83d-e063-dadaa90ab31f0d018b4b-16b9-8ea3-e063-6294a90a18ba
83778-006-022025-01-30C16284748780-12cef2736-883b-d83d-e063-dadaa90ab31f0d018b4b-16b9-8ea3-e063-6294a90a18ba
83778-006-032025-01-30C16284748780-12cef2736-883b-d83d-e063-dadaa90ab31f0d018b4b-16b9-8ea3-e063-6294a90a18ba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-006-01Neateeth Teeth Whitening Strips7 in 1 BOXPATCH71
83778-006-02Neateeth Teeth Whitening Strips14 in 1 BOXPATCH141
83778-006-03Neateeth Teeth Whitening Strips21 in 1 BOXPATCH211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83778-006NEATEETH TEETH WHITENING STRIPS PATCH [NANCHANG DENTAL BRIGHT TECHNOLOGY CO.,LTD.]13 package rows20231222_0d018b4b-16b9-8ea3-e063-6294a90a18ba.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83778-00683778-006-01, 83778-006-02, 83778-006-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
POVIDONE K30U725QWY32XIACT
PHTHALIMIDOPEROXYCAPROIC ACID5OEJ6FAL6CACTIB
XYLITOLVCQ006KQ1EIACT
POVIDONE K90RDH86HJV5ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT

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
0d018b4b-16ba-8ea3-e063-6294a90a18ba0d018b4b-16b9-8ea3-e063-6294a90a18ba2023-12-21WarningsExact identifier
spl id: 0d018b4b-16ba-8ea3-e063-6294a90a18ba
spl set id: 0d018b4b-16b9-8ea3-e063-6294a90a18ba

Reported adverse events (FAERS/openFDA)#

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