Label: PURPLE TOOTH- purple toothpaste paste

  • NDC Code(s): 82168-005-01
  • 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

    Calcium Carbonate, Aqua (Water), Glycerin, Sorbito, Slica, Aroma (Flavour), Sodium Lauryl Sulphate,

    Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hyoroyetlhl-llulose, Chondrus Crispus (arrageenan),

    Sodium Saccharin, Rosa Canina Fruit 0i, CI 77891

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    PURPLE TOOTH 
    purple toothpaste paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82168-005
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SILICA (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CELLULOSE GUM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82168-005-01100 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(82168-005)
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