Teeth Whitening Strips

Manufacturer
Nanchang Dental Bright Technology Co.,Ltd.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:51

Label at a glance#

ProductTeeth Whitening Strips
Active ingredientPHTHALIMIDOPEROXYCAPROIC ACID
Label structure13 sections

Dosage and administration

1. Remove strips from backer. 2. Apply upper strip to top teeth, and repeat with bottom teeth. 3. Leave for 30 minutes, avoid eating or drinking. 4. 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(PAP)

Purpose

OTC - PURPOSE SECTION

Teeth Whitening

Use

INDICATIONS & USAGE SECTION

Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration.

Warnings

WARNINGS SECTION

1. Not intended for children under 16.
2. Do not swallow strip.
3. Avoid contact of strips with eyes or skin.
4. If the strip comes into contact with skin, it may cause temporary skin irritation.
5. If there is any discomfort, please stop using and consult a dentist immediately
6. Not suitable for people who have ulcers, exposed gums or after oral surgery.

Do not use

OTC - DO NOT USE SECTION

Not intended for children under 16.
Not suitable for people who have ulcers, exposed gums or after oral surgery.

When Using

OTC - WHEN USING SECTION

1. Avoid using strips after brushing your teeth. Allow at least one hour after brushing teeth before using the strips.
2. Do not re-use the strips, please dispose of once used.
3. The ingredients of the strips are safe and if some gel is swalloed, it is perfectly safe.
4. Clean off any remaining gel residue by brushing your teeth and gargling.

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. Remove strips from backer.
2. Apply upper strip to top teeth, and repeat with bottom teeth.
3. Leave for 30 minutes, avoid eating or drinking.
4. 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

Glycerin、Water/Aqua、PVP、Ethylcellulose、Alcohol、Sodium Polyacrylate、Xylitol、Potassium Citrate、Hydroxyapatite、Rebaudioside A 、Menthol、Sodium Citrate、Xanthan Gum、PVM/MA Copolymer、C12-15Pareth-3

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83778-003-012025-01-30C16284748780-12cef2736-6b6c-d83d-e063-dadaa90ab31f097478f1-9b47-b749-e063-6394a90a9977

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83778-003-01Teeth Whitening Strips14 in 1 BOXPATCH141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83778-003TEETH WHITENING STRIPS PATCH [NANCHANG DENTAL BRIGHT TECHNOLOGY CO.,LTD.]11 package rows20231106_097478f1-9b47-b749-e063-6394a90a9977.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83778-00383778-003-01

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
097478f1-9b48-b749-e063-6394a90a9977097478f1-9b47-b749-e063-6394a90a99772023-11-05WarningsExact identifier
spl id: 097478f1-9b48-b749-e063-6394a90a9977
spl set id: 097478f1-9b47-b749-e063-6394a90a9977

Reported adverse events (FAERS/openFDA)#

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