Label: V34 COLOUR CORRECTOR cream

  • NDC Code(s): 83778-001-01
  • 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 October 31, 2023

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

  • Active Ingredient

    Tetrasodium Pyrophosphate

  • Purpose

    Teeth cleaning

  • Use

    Those who want to clean and whiten their teeth.

  • Warnings

    Product is not intended for use by children. Do not swallow. Do not use in eye area.

  • Do not use

    Product is not intended for use by children.

  • When Using

    Do not swallow. Do not use in eye area.

  • Stop Use

    If there is any discomfort, please stop using.

  • Ask Doctor

    If there is any discomfort, please consult a dentist immediately

  • Keep Oot Of Reach Of Children

    keep out of reach of young children

  • Directions

    1. Apply 2 pumps to a soft bristle toothbrush.
    2. Gently brush it a circular motion for 2 minutes.
    3. Expel excess and rinse mouth after use, do not swallow.

  • Other information

    please keep in dry and cool place

  • Inactive ingredients

    Glycerin、Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Polysorbate 80、Cellulose Gum、Mentha Piperita(peppermint) oil 、Phenoxyethanol、Sucralose、Ethylhexylglycerin、CI17200/D&C Red No.33、CI 42090/FD&C Blue No.1

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    V34 COLOUR CORRECTOR 
    v34 colour corrector cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83778-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/30/2023
    Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanchang Dental Bright Technology Co.,Ltd.544503502label(83778-001) , manufacture(83778-001)