TEETH WHITENING STRIPS patch

Teeth Whitening Strips by

Drug Labeling and Warnings

Teeth Whitening Strips by is a Otc medication manufactured, distributed, or labeled by Nanchang Dental Bright Technology Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TEETH WHITENING STRIPS 
teeth whitening strips patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83778-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C)	PHTHALIMIDOPEROXYCAPROIC ACID	12 g  in 100

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83778-003-01	14 in 1 BOX; Type 0: Not a Combination Product	11/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/05/2023

Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)

Establishment
Name	Address	ID/FEI	Business Operations
Nanchang Dental Bright Technology Co.,Ltd.		544503502	label(83778-003) , manufacture(83778-003)