Label: SARASOTA MEMORIAL AMENITY- alcohol and sodium monofluorophosphate kit

  • NDC Code(s): 42555-060-45, 59448-004-01, 59448-600-00
  • 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 15, 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

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

    Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    Avoid contact with broken skin.

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help.

  • Directions

    Not recommended for infants.

    Wet hands thoroughly with product and allow to dry without wiping.

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

  • Other Information

    Do not store above 110°F. May discolor some fabrics.

  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

    ASP
    MEDICAL

    Instant Hand Antiseptic
    62% w/w Ethyl Alcohol

    1.9 FL OZ / 53 mL

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

    Rev 01

    PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
  • 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

    SARASOTA
    MEMORIAL
    HEALTH CARE SYSTEM

    Contents/Origins:

    1.9 fl. oz. Hand Sanitizer
    Toothbrush, Sleep Mask, Ear Plugs, Facial Tissue, Patient
    Hand Hygiene Education Card, Paper Bag 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, USA

    REV 02

    SARASOTA
    MEMORIAL
    HEALTH CARE SYSTEM

    Item #: SARASOTA01
    Description: AMENITY KIT, SARASOTA
    MEM WELCOME
    PO #:
    Lot #: XMMDDFC
    Exp: YYYY-MM-DD
    Qty: 30 KIT/CS
    Carton #: XXX of XXX
    Net Wt.: XX KG
    Gross Wt.: XX KG
    Cubic Dimensions: XX x XX x XX CM
    Assembled in China

    Components Made in China:

    • Hand Sanitizer
    • Toothbrush
    • Sleep Mask
    • Ear Plugs
    • Facial Tissue
    • Paper Bag
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    SARASOTA
    MEMORIAL
    HEALTH CARE SYSTEM

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    SARASOTA MEMORIAL AMENITY 
    alcohol and sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-600
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-600-0030 in 1 BOX10/08/2019
    11 in 1 BAG
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 53 mL
    Part 21 TUBE 10 g
    Part 1 of 2
    INSTANT HAND ANTISEPTIC 
    alcohol gel
    Product Information
    Item Code (Source)NDC:59448-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-004-0153 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 FINALpart333E11/27/2018
    Part 2 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)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/08/2019
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-600) , LABEL(59448-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-600)
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