Label: TEETHWHITENING KIT cream
- NDC Code(s): 83778-012-01
- Packager: Nanchang Dental Bright Technology Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
- STOP USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & 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.
- INACTIVE INGREDIENT
- WARNINGS
-
INDICATIONS & 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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TEETHWHITENING KIT
teethwhitening kit creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83778-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE 3 g in 100 mL PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID 12 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 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) GLYCERIN (UNII: PDC6A3C0OX) PEPPERMINT OIL (UNII: AV092KU4JH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MICA (UNII: V8A1AW0880) AQUA (UNII: 059QF0KO0R) PVP (UNII: FZ989GH94E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83778-012-01 6 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/14/2024 Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502) Establishment Name Address ID/FEI Business Operations Nanchang Dental Bright Technology Co.,Ltd. 544503502 manufacture(83778-012) , label(83778-012)
