Label: PROFESSIONAL WHITENING TOOTH- professional whitening toothpaste paste

  • NDC Code(s): 82168-004-01
  • Packager: Guangzhou City Caiye Cosmetics CO., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active Ingredient(s)

    Sodium monofluorophosphate 0.76%

  • Purpose

    Anticavity tothpaste

  • Use

    Use helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for brushing is
    acidentally sallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    Do not use on open skin wounds

  • WHEN USING

    Please keep away from your eyes when using this product

  • STOP USE

    If in contact with the eyes, rinse thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • Directions

    Adults and children 2 years of age & older: Brush teth thoroughly, preferably after each meal or at least twice a day, or as directed by
    a dentist or doctor.
    Children under 6 years of age: Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary

    until capable of using without supervision,

    Children under 2 years of age: Consult a dentist or doctor.

  • Other information

    Store in a cool place below 86° F away from heat
    Do not use if quality seal is broken or missing

  • Inactive ingredients

    Calium Carbonate, Water, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl
    Sulfate, Aawour, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Cellulose
    Gum, Hydroyethylollulose, Benzyl Alcohol, Tetrasodium Pyrophosphate, Rosa
    Canina (Rose hip) Fruit 0il.

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    PROFESSIONAL WHITENING TOOTH 
    professional whitening toothpaste paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82168-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICA (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE GUM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82168-004-01100 g in 1 BOX; Type 0: Not a Combination Product12/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/13/2024
    Labeler - Guangzhou City Caiye Cosmetics CO., Ltd (527929008)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou City Caiye Cosmetics CO., Ltd527929008manufacture(82168-004)
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