Label: UNIV OF VERMONT MEDICAL CENTER AMENITY- benzalkonium chloride and sodium monofluorophosphate kit

  • NDC Code(s): 42555-060-45, 59448-003-01, 59448-500-00
  • 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 14, 2022

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

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Instant Hand Antiseptic

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.095%

  • Propose

    Antiseptic

  • Uses

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes and lips. If contact occurs, rinse with water.

    Stop use and ask a doctor if irritation or redness develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Rub dime sized amount between hands until dry.

    Children under 6 years of age should be supervised when using this product.

  • Inactive Ingredients

    Glycerin, Methylisothiazolinone, Propylene Glycol, Polyquaternium-37, Triethanolamine, Water

  • SPL UNCLASSIFIED SECTION

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

  • 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 - 53 mL Bottle Label

    ASP
    MEDICAL

    Instant Hand Antiseptic
    Alcohol & Fragrance Free

    1.9 FL OZ / 53 mL

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

    Rev 02

    PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - Kit Label

    We strive to provide a quiet environment for you
    to rest in during your stay. This Welcome Packet
    contains some items that are helpful in reducing
    hospital noise.

    The best healing happens in a quiet environment.

    You can help by:

    • Using a headset when watching TV
    • Keeping cell phones on vibrate
    • Speaking softly
    • Asking family and friends to visit two at a time

    We are honored to care for you.

    Contents/Origins:
    1.9 fl. oz. Alcohol and Fragrance Free Hand Sanitizer,
    0.15 oz. net wt. Lip Balm,
    Toothbrush, Sleep Mask, Ear Plugs, Notebook, Pen and
    Kit Case: Made in China
    Toothpaste: Made in Thailand

    Lot #: XMMDDFC
    Exp: YYYY-MM-DD

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

    REV 01

    THE
    University of Vermont
    MEDICAL CENTER

    Item #: UNVMC01
    Description: AMENITY KIT, UVMC,
    GREEN, ZIPPERED
    PO #:
    Lot #: XMMDDFC
    Exp: YYYY-MM-DD
    Qty: 30 KIT/CS
    Carton #: XXX of XXXX
    Net Wt.: XX KG
    Gross Wt.: XX KG
    Cubic Dimensions: 57.0 x 17.0 x 27.0 CM
    Assembled in China

    Components Made in China:

    • Alcohol and Fragrance Free Hand Sanitizer
    • Lip Balm
    • Toothbrush
    • Sleep Mask
    • Ear Plugs
    • Notebook
    • Pen
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    THE
    University of Vermont
    MEDICAL CENTER

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    UNIV OF VERMONT MEDICAL CENTER AMENITY 
    benzalkonium chloride and sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-500
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-500-0020 in 1 BOX12/05/2018
    11 in 1 BAG
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 53 mL
    Part 21 TUBE 10 g
    Part 31 TUBE 4.25 g
    Part 1 of 3
    INSTANT HAND ANTISEPTIC 
    benzalkonium chloride gel
    Product Information
    Item Code (Source)NDC:59448-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.095 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polyquaternium-37 (25000 MPA.S) (UNII: 31L31U8285)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-003-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/05/2018
    Part 2 of 3
    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 3 of 3
    ASP GLOBAL  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
    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
    Cosmetic12/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/05/2018
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-500) , LABEL(59448-500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-500)
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