SPL v2
SPL
SPL Set ID 29393313-217a-dc3a-e063-6294a90addb1
Route
TOPICAL
Published
Effective Date 2024-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (3 g) Phthalimidoperoxycaproic Acid (12 g) Phosphate Ion (1 g)
Inactive Ingredients
Ammonium Acryloyldimethyltaurate/vp Copolymer Pvp Glycerin Peppermint Oil Saccharin Sodium Titanium Dioxide Piroctone Olamine Potassium Hydroxide Mica Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-14

Description

Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite


Medication Information

Warnings and Precautions



Don't swallow. Avoid applying gel on the gum and lips.Avoid sunlight and keep in dry & cool place

Indications and Usage

1. Dry your teeth and rinse mouthpiece before use

2. Looking in the mirror to recor which stage you are with shadeyuide paper.

3. Twist whitening pen until the gel flows. apply the gel evenly on bath upper and lower..teeth. Each time use about 0.5-0.7ml

4. Put mouthpiece into your mouth and bite it, then press power bltton for 1.5 secondst with blue color, press again to turn red within 5 to start the treatment.(Tips: stad and blue within 5 seconds.)seconds; double press to turn re

5. The led light will turn off automatically after 16 minutes, rinse themouthpiece andmouth with water and compareour teeth with shade guide paperagain to see howmany stages you have improved

6. Don't eat or drink anything exept water in 30 minutes after treatment.

Dosage and Administration



1. Dry your teeth and rinse mouthpiece before use.

2. Looking in the mirror to record which stage you are with shade guide paper.

3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower

teeth. Each time use about 0.5-0.7ml.

4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds

to start the treatment. (Tips: start with blue color, press again to turn red within 5

seconds; double press to turn red and blue within 5 seconds.)

5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and

mouth with water and compare your teeth with shade guide paper again to see how

many stages you have improved.

6. Don't eat or drink anything except water in 30 minutes after treatment.

Description

Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop treatment when feel severe pain

Section 50567-7

Don't swallow. Avoidapplying gel on the gum and lips.

Section 50569-3

Stop treatment when feel severe pain

Section 51727-6



Glycerin􀀀Aqua􀀀Polyvinylpyrrolidone(PVP)􀀀Ammonium

Acryloyldimethyltaurate/VP Copolymer􀀀Potassium Hydroxide􀀀Mentha Piperita

(peppermint) oil 􀀀Mica􀀀Titanium Dioxide􀀀Saccharin Sodium􀀀Piroctone Olamine

PRINCIPAL DISPLAY

Section 51945-4

Section 55105-1

Teeth whitening, anti-sensitivity, remineralization

Section 55106-9



Phthalimidoperoxycaproic Acid(PAP)

Potassium Citrate

Hydroxyapatite


Structured Label Content

Indications and Usage (34067-9)

1. Dry your teeth and rinse mouthpiece before use

2. Looking in the mirror to recor which stage you are with shadeyuide paper.

3. Twist whitening pen until the gel flows. apply the gel evenly on bath upper and lower..teeth. Each time use about 0.5-0.7ml

4. Put mouthpiece into your mouth and bite it, then press power bltton for 1.5 secondst with blue color, press again to turn red within 5 to start the treatment.(Tips: stad and blue within 5 seconds.)seconds; double press to turn re

5. The led light will turn off automatically after 16 minutes, rinse themouthpiece andmouth with water and compareour teeth with shade guide paperagain to see howmany stages you have improved

6. Don't eat or drink anything exept water in 30 minutes after treatment.

Dosage and Administration (34068-7)



1. Dry your teeth and rinse mouthpiece before use.

2. Looking in the mirror to record which stage you are with shade guide paper.

3. Twist whitening pen until the gel flows. apply the gel evenly on both upper and lower

teeth. Each time use about 0.5-0.7ml.

4. Put mouthpiece into your mouth and bite it, then press power button for 1.5 seconds

to start the treatment. (Tips: start with blue color, press again to turn red within 5

seconds; double press to turn red and blue within 5 seconds.)

5. The led light will turn off automatically after 16 minutes, rinse the mouthpiece and

mouth with water and compare your teeth with shade guide paper again to see how

many stages you have improved.

6. Don't eat or drink anything except water in 30 minutes after treatment.

Warnings and Precautions (34071-1)



Don't swallow. Avoid applying gel on the gum and lips.Avoid sunlight and keep in dry & cool place

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop treatment when feel severe pain

Section 50567-7 (50567-7)

Don't swallow. Avoidapplying gel on the gum and lips.

Section 50569-3 (50569-3)

Stop treatment when feel severe pain

Section 51727-6 (51727-6)



Glycerin􀀀Aqua􀀀Polyvinylpyrrolidone(PVP)􀀀Ammonium

Acryloyldimethyltaurate/VP Copolymer􀀀Potassium Hydroxide􀀀Mentha Piperita

(peppermint) oil 􀀀Mica􀀀Titanium Dioxide􀀀Saccharin Sodium􀀀Piroctone Olamine

PRINCIPAL DISPLAY

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Teeth whitening, anti-sensitivity, remineralization

Section 55106-9 (55106-9)



Phthalimidoperoxycaproic Acid(PAP)

Potassium Citrate

Hydroxyapatite


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)