Label: EMORY JOHNS CREEK AMENITY- alcohol and sodium monofluorophospate kit

  • NDC Code(s): 42555-060-45, 59448-004-01, 59448-700-00
  • 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

    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

    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

    EMORY
    JOHNS CREEK
    HOSPITAL

    Item #: EJCKIT01
    Description: AMENITY KIT,
    EMORY JOHNS CREEK
    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: 54.0 x 19.0 x 27.0 CM

    Assembled in China

    Components Made in China:

    • Alcohol and Fragrance Free Hand Sanitizer
    • Lip Balm Ball
    • Toothbrush
    • Sleep Mask
    • Ear Plugs
    • Body Lotion
    • Deodorant Stick
    • Kit Case

    Component Made in Thailand:

    • Toothpaste

    EMORY
    JOHNS CREEK
    HOSPITAL

    On behalf of the entire Emory Johns Creek Hospital family,
    we thank you for trusting us with your care. Our goal is to
    provide all our patients with a nurturing and healing
    environment, and we hope this kit adds to your comfort
    during your stay. Please let us know what we can do to
    make your stay more comfortable.

    Contents/Origins:

    1.9 fl. oz. Hand Sanitizer,
    0.25 oz. net wt. Lip Balm Ball,
    2 fl. oz. Body Lotion,
    0.5 oz. net wt. Deodorant Stick,
    Toothbrush, Sleep Mask, Ear Plugs, 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

    EMORY
    JOHNS CREEK
    HOSPITAL

    PRINCIPAL DISPLAY PANEL - Kit Label
  • INGREDIENTS AND APPEARANCE
    EMORY JOHNS CREEK AMENITY 
    alcohol and sodium monofluorophospate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-700
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59448-700-0030 in 1 BOX07/27/2020
    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 59 mL
    Part 41 TUBE 4.25 g
    Part 51 BOTTLE, WITH APPLICATOR 14 g
    Part 1 of 5
    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 FINALpart333E10/15/2019
    Part 2 of 5
    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 5
    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 5
    EMORY JOHNS CREEK   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
    ColorYELLOWScore    
    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
    COSMETIC06/13/2018
    Part 5 of 5
    GILCHRIST AND SOAMES   DEODORANT
    deodorants (underarm)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRStearic Acid (UNII: 4ELV7Z65AP)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRSodium Hydroxide (UNII: 55X04QC32I)  
    INGRWHITE WAX (UNII: 7G1J5DA97F)  
    INGRStarch, Rice (UNII: 4DGK8B7I3S)  
    INGRLavender Oil (UNII: ZBP1YXW0H8)  
    INGRTannic Acid (UNII: 28F9E0DJY6)  
    INGRSodium Lactate (UNII: TU7HW0W0QT)  
    INGRButylene Glycol (UNII: 3XUS85K0RA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBenzyl Alcohol (UNII: LKG8494WBH)  
    INGRCoumarin (UNII: A4VZ22K1WT)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC10/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/27/2020
    Labeler - ASP Global, LLc (080361159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengzhou Kingbird Travel Products Co., Ltd.560219293PACK(59448-700) , LABEL(59448-700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive (Thailand) LTD672044552MANUFACTURE(59448-700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161MANUFACTURE(59448-700)
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