Label: TEETH WHITENING KIT cream

  • NDC Code(s): 83778-002-01
  • Packager: Nanchang Dental Bright Technology 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 5, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Phthalimidoperoxycaproic Acid(PAP)
    Potassium Citrate
    Hydroxyapatite

  • Purpose

    Teeth whitening, anti-sensitivity, remineralization

  • Use

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

  • Warnings

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

  • 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.

  • Stop Use

    Stop treatment when feel severe pain

  • Ask Doctor

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

  • Keep Oot Of Reach Of Children

    Keep out of reach of children.

  • 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.

  • Other information

  • 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

    01

  • INGREDIENTS AND APPEARANCE
    TEETH WHITENING KIT 
    teeth whitening kit cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE1 g  in 100 mL
    POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE3 g  in 100 mL
    PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MICA (UNII: V8A1AW0880)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83778-002-016 mL in 1 BOTTLE; Type 0: Not a Combination Product11/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/05/2023
    Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanchang Dental Bright Technology Co.,Ltd.544503502label(83778-002) , manufacture(83778-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!