5G COLGATE PLUS TOOTHBRUSH KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [COLGATE-PALMOLIVE (THAILAND) LIMITED - BRANCH]

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  • 5G COLGATE PLUS TOOTHBRUSH KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [COLGATE-PALMOLIVE (THAILAND) LIMITED - BRANCH]

5G COLGATE PLUS TOOTHBRUSH KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [COLGATE-PALMOLIVE (THAILAND) LIMITED - BRANCH]
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NDC 42555-000-01, 42555-060-94
Set ID fcb1916a-883a-4611-a253-efd880bc5ae1
Category HUMAN OTC DRUG LABEL
Packager Colgate-Palmolive (Thailand) Limited - Branch
Generic Name
Product Class
Product Number
Application Number PART355
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  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

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

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

     adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
     children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
     children under 2 years ask a dentist or physician 

  • Inactive ingredients

    dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

  • Questions or comments?

    Call to-free 1-800-468-6502

  • Package Labeling:

    LabelLabel2Tooth Brush and Tube Photo

  • INGREDIENTS AND APPEARANCE
    5G COLGATE PLUS TOOTHBRUSH KIT 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42555-000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-000-011 in 1 KIT06/07/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 5 g
    Part 1 of 1
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:42555-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-060-945 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/07/2018
    Labeler - Colgate-Palmolive (Thailand) Limited - Branch (672044552)
    Establishment
    NameAddressID/FEIBusiness Operations
    Luoding Quality Amenities Supply Limited528126807repack(42555-000, 42555-060)
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