Label: TEETH WHITENING KIT liquid
- NDC Code(s): 83812-001-01
- Packager: LLRN PERSONAL CARE(SHENZHEN)CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated November 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- When Using
- Stop Use
- Ask Doctor
- Keep Oot Of Reach Of Children
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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. - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TEETH WHITENING KIT
teeth whitening kit liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83812-001 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 mL POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE 3 g in 100 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POVIDONE (UNII: FZ989GH94E) SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PEPPERMINT OIL (UNII: AV092KU4JH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83812-001-01 6 mL in 1 BOX; Type 1: Convenience Kit of Co-Package 11/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/21/2023 Labeler - LLRN PERSONAL CARE(SHENZHEN)CO., LTD (419890311) Establishment Name Address ID/FEI Business Operations LLRN PERSONAL CARE(SHENZHEN)CO., LTD 419890311 label(83812-001) , manufacture(83812-001)