83778-002 Update

83778-002 Update
SPL v2
SPL
SPL Set ID 0973b73d-5de9-0986-e063-6294a90a5917
Route
TOPICAL
Published
Effective Date 2023-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (1 g) Phthalimidoperoxycaproic Acid (12 g) Anhydrous Citric Acid (3 g)
Inactive Ingredients
Water Povidone Potassium Hydroxide Peppermint Oil Mica Saccharin Sodium Titanium Dioxide Piroctone Olamine Sodium Acryloyldimethyltaurate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-11-05

Description

Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite

Purpose

Teeth whitening, anti-sensitivity, remineralization


Medication Information

Purpose

Teeth whitening, anti-sensitivity, remineralization

Description

Phthalimidoperoxycaproic Acid(PAP) Potassium Citrate Hydroxyapatite

Use

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

Stop Use

Stop treatment when feel severe pain

Warnings

Don't swallow. Avoid applying gel on the gum and lips.

Ask Doctor

Seek doctor's advice prior to use if pregnant, breast-feeding, having gum problem or had an oral operation recently

Directions

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.

Do Not Use

1. Not suitable for ceramic or false teeth.

2. Not suitable for teeth discoloration caused by lesion or medicine.

3. Not suitable for severe tetracycline and decayed teeth.

4. Not suitable for defective enamel, exerted dentin and damaged teeth.

5. Not suitable for children under 16 years old

When Using

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

Active Ingredient

Phthalimidoperoxycaproic Acid(PAP)

Potassium Citrate

Hydroxyapatite

Other Information

Avoid sunlight and keep in dry & cool place

Inactive Ingredients

Glycerin、Aqua、Polyvinylpyrrolidone(PVP)、Ammonium

Acryloyldimethyltaurate/VP Copolymer、Potassium Hydroxide、Mentha Piperita (peppermint) oil 、Mica、Titanium Dioxide、Saccharin Sodium、Piroctone Olamine

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children.


Structured Label Content

Use

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

Purpose

Teeth whitening, anti-sensitivity, remineralization

Stop Use

Stop treatment when feel severe pain

Warnings

Don't swallow. Avoid applying gel on the gum and lips.

Ask Doctor

Seek doctor's advice prior to use if pregnant, breast-feeding, having gum problem or had an oral operation recently

Directions

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.

Do Not Use (Do not use)

1. Not suitable for ceramic or false teeth.

2. Not suitable for teeth discoloration caused by lesion or medicine.

3. Not suitable for severe tetracycline and decayed teeth.

4. Not suitable for defective enamel, exerted dentin and damaged teeth.

5. Not suitable for children under 16 years old

When Using

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

Active Ingredient

Phthalimidoperoxycaproic Acid(PAP)

Potassium Citrate

Hydroxyapatite

Other Information (Other information)

Avoid sunlight and keep in dry & cool place

Inactive Ingredients (Inactive ingredients)

Glycerin、Aqua、Polyvinylpyrrolidone(PVP)、Ammonium

Acryloyldimethyltaurate/VP Copolymer、Potassium Hydroxide、Mentha Piperita (peppermint) oil 、Mica、Titanium Dioxide、Saccharin Sodium、Piroctone Olamine

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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