Label: GRACIE SQUARE HOSPITAL AMENITY- sodium monofluorophosphate kit

  • 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 September 13, 2019

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  • SPL UNCLASSIFIED SECTION

    Colgate® Anticavity Toothpaste

    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 yearsask 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

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

    NET WT 10g

    Principal Display Panel - 10 g Tube Label
  • PRINCIPAL DISPLAY PANEL - Kit Label

    GRACIE
    SQUARE
    HOSPITAL

    Item #: GSHAMEN01

    Description: Amenity Kit

    PO #:

    Lot #: XMMDDFC

    Exp: YYYY-MM-DD

    Qty: 20 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:

    • Shampoo/Conditioner
    • Body Wash
    • Body Lotion
    • Alcohol-Free Mouthwash
    • Hair Brush
    • Toothbrush
    • Ear Plugs
    • Lip Balm
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    GRACIE
    SQUARE
    HOSPITAL

    We are pleased to
    present this welcome kit
    for your comfort and
    convenience during your
    stay.

    Thank you for choosing
    Gracie Square Hospital
    for your healthcare!

    Contents/Origins:

    2.0 fl. oz. Shampoo/Conditioner
    2.0 fl. oz. Body Wash
    2.0 fl. oz. Body Lotion
    2.2 fl. oz. Alcohol-Free Mouthwash
    0.15 oz. net wt. Lip Balm
    Hair Brush, Toothbrush, Ear Plugs,
    and Kit Case: Made in China
    Toothpaste: Made in Thailand

    Lot #:
    Exp:

    Distributed by:
    ASP Global, LLC
    3450 Atlanta Industrial Parkway
    Atlanta, GA 30331

    GSHAMEN01 Rev 2

    GRACIE
    SQUARE
    HOSPITAL

    Principal Display Panel - Kit Label
  • INGREDIENTS AND APPEARANCE
    GRACIE SQUARE HOSPITAL AMENITY 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-101
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-101-001 in 1 BAG01/18/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 10 g
    Part 21 TUBE 59 mL
    Part 31 TUBE 59 mL
    Part 41 TUBE 59 mL
    Part 51 TUBE 4.25 g
    Part 61 BOTTLE, PLASTIC 65 mL
    Part 1 of 6
    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)  
    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 6
    GILCHRIST AND SOAMES   BODY BUTTER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    colorWHITEC48325
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Part 3 of 6
    GILCHRIST AND SOAMES   HAIR 2 IN 1
    shampoos (non-coloring)
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    colorYELLOWC48330
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Part 4 of 6
    GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
    skin fresheners
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)  
    INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
    INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    colorGREENC48329
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Part 5 of 6
    GILCHRIST AND SOAMES   MOISTURIZING LIP BALM
    lipstick
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCERESIN (UNII: Q1LS2UJO3A)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGRPETROLATUM (UNII: 4T6H12BN9U)  
    INGRHYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    INGRPOLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    INGRMICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    INGRCANDELILLA WAX (UNII: WL0328HX19)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRPENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)  
    Product Characteristics
    colorYELLOWC48330
    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
    Cosmetic07/01/2013
    Part 6 of 6
    ASP GLOBAL, LLC   ALCOHOL-FREE
    mouthwashes and breath fresheners (liquids and sprays)
    Product Information
    Route of AdministrationORAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRMENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    colorBLUEC48333
    flavorMINTC73404
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/18/2016
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-101) , LABEL(59448-101) , REPACK(59448-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-101)
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