TEETH WHITENING STRIPS- teeth whitening strips patch 
Nanchang Dental Bright Technology Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient

Phthalimidoperoxycaproic Acid(PAP)

Purpose

Teeth Whitening

Use

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

Warnings

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

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

When Using

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

If there is any discomfort, please stop using.

Ask Doctor

If there is any discomfort, please consult a dentist immediately

Keep Oot Of Reach Of Children

keep out of reach of young children

Directions

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

please keep in dry and cool place

Inactive ingredients

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

1

TEETH WHITENING STRIPS 
teeth whitening strips patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID12 g  in 100 
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
METHYL VINYL ETHER AND MALEIC ANHYDRIDE COPOLYMER (1100000 WAMW) (UNII: T0VRI38HB0)  
C12-15 PARETH-3 (UNII: 459EF9MP3Y)  
POVIDONE (UNII: FZ989GH94E)  
ALCOHOL (UNII: 3K9958V90M)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
WATER (UNII: 059QF0KO0R)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83778-003-0114 in 1 BOX; Type 0: Not a Combination Product11/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/05/2023
Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)
Establishment
NameAddressID/FEIBusiness Operations
Nanchang Dental Bright Technology Co.,Ltd.544503502label(83778-003) , manufacture(83778-003)

Revised: 11/2023
Document Id: 097478f1-9b48-b749-e063-6394a90a9977
Set id: 097478f1-9b47-b749-e063-6394a90a9977
Version: 1
Effective Time: 20231105
 
Nanchang Dental Bright Technology Co.,Ltd.