Label: NORTHSIDE HOSPITAL AMENITY KIT- alcohol and sodium monofluorophospate kit

  • NDC Code(s): 42555-060-45, 59448-001-02, 59448-200-00
  • 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 March 1, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • 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

  • PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

    NORTHSIDE HOSPITAL

    Instant Hand Antiseptic
    62% w/w Ethyl Alcohol

    Creating a Healing Environment

    We provide our patients with the essentials
    they need to stay well rested.
    This is an important part of healing,
    both here and at home.

    1.9 FL OZ / 53 mL

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

    Rev 03-2021

    Principal Display Panel - 53 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 g Tube Label

    Colgate®
    Anticavity Toothpaste

    Cavity
    Protection

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

    NORTHSIDE HOSPITAL

    Item #: NSAMENK01
    Description: Amenity Kit, Main

    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
    • Face Mask
    • Hairbrush
    • Toothbrush
    • Hand Sanitizer
    • Lip Balm
    • Ear Plugs
    • Eye Mask
    • Facial Tissue
    • Pen
    • Sudoku Book
    • Questions for My Care Team Book
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    NORTHSIDE HOSPITAL

    Creating a Healing Environment

    We provide our patients with the essentials
    they need to stay well rested.
    This is an important part of healing,
    both here and at home.

    Lot #:
    Exp:

    Contents/Origins:

    2.0 fl. oz. Shampoo/Conditioner
    2.0 fl. oz. Body Wash
    2.0 fl. oz. Body Lotion
    2.0 fl. oz. Alcohol-Free Mouthwash
    0.15 oz. net wt. Lip Balm
    1.9 fl. oz. Hand Sanitizer
    Toothbrush, Hairbrush, Ear Plugs, Eye Mask, Facial Tissue,
    Face Mask, Pen, Puzzle Book, Questions for My Care Team
    Book, 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 07

    NORTHSIDE HOSPITAL

    Principal Display Panel - Kit Label
  • INGREDIENTS AND APPEARANCE
    NORTHSIDE HOSPITAL AMENITY KIT 
    alcohol and sodium monofluorophospate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-200
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-200-001 in 1 BAG01/18/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 53 mL
    Part 21 TUBE 10 g
    Part 31 TUBE 59 mL
    Part 41 TUBE 59 mL
    Part 51 TUBE 59 mL
    Part 61 TUBE 4.25 g
    Part 71 BOTTLE, PLASTIC 65 mL
    Part 1 of 7
    INSTANT HAND ANTISEPTIC 
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:59448-001
    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:59448-001-0253 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 FINALpart333E12/18/2015
    Part 2 of 7
    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 7
    GILCHRIST AND SOAMES   BODY BUTTER
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    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 7
    GILCHRIST AND SOAMES   HAIR 2 IN 1
    shampoos (non-coloring)
    Product Information
    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
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    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 7
    GILCHRIST AND SOAMES   BODY REFRESHER--BODY WASH
    skin fresheners
    Product Information
    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
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    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 6 of 7
    NORTHSIDE HOSPITAL   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
    COSMETIC11/01/2016
    Part 7 of 7
    ASP GLOBAL, LLC   ALCOHOL-FREE
    mouthwashes and breath fresheners (liquids and sprays)
    Product Information
    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
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    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(59448-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!