Label: MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT- sodium monofluorophosphate kit

  • NDC Code(s): 42555-060-45, 59448-300-00
  • Packager: ASP Global, LLc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 1, 2022

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  • SPL UNCLASSIFIED SECTION

    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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse 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, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    COLGATE-PALMOLIVE (THAILAND) Limited,     Chonburi 20000, Thailand.

  • PRINCIPAL DISPLAY PANEL - 10 g Tube Label

    P1505037

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

    NET WT 10g

    7
    OTHER

    PRINCIPAL DISPLAY PANEL - 10 g Tube Label
  • PRINCIPAL DISPLAY PANEL - Kit Label

    Memorial Sloan Kettering
    Cancer Center

    Contents/Origins:

    0.15 oz. net wt. Lip Balm
    Toothbrush, Ear Plug, Sleep Mask, Facial Tissue,
    Denture Cup, Headphone, Notepad, Patient Name Card,
    Welcome Card, Sudoku/Crossword Book, My Care
    Booklet, Ballpen, and Kit Case: Made in China
    Toothpaste: Made in Thailand

    Lot #:
    Exp:

    Distributed by:
    ASP Global, LLC
    7800 Third Flag Parkway,
    Austell, GA 30168, USA
    REV 02

    Memorial Sloan Kettering
    Cancer Center

    Item #: MSKAKT01
    Description: Amenity Kit

    PO #:
    Lot #: XMMDDFC
    Exp: YYYY-MM-DD
    Qty: 30 KIT/CS
    Carton #: X of XX
    Net Wt.: XX KG
    Gross Wt.: XX KG
    Cubic Dimensions: NN x NN x NN CM

    Assembled in China

    Components Made in China:

    • Lip Balm
    • Toothbrush
    • Ear Plug
    • Sleep Mask
    • Facial Tissue
    • Denture Cup
    • Headphone
    • Notepad
    • Patient Name Card
    • Welcome Card
    • Sudoku/Crossword Book
    • My Care Booklet
    • Ballpen
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    Memorial Sloan Kettering
    Cancer Center

    Name Card

    Patient Name:

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    MEMORIAL SLOAN KETTERING CANCER CENTER AMENITY KIT 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-300
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-300-001 in 1 BAG04/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 10 g
    Part 21 TUBE 4.25 g
    Part 1 of 2
    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
    Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)  
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium, Unspecified (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:42555-060-4510 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/04/2009
    Part 2 of 2
    MEMORIAL SLOAN KETTERING CANCER CENTER   LIP BALM
    lipstick
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRPOLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    INGRSHEANUT OIL (UNII: O88E196QRF)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC04/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/01/2017
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-300) , LABEL(59448-300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-300)
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