ISLAND COTTON (ANTIBACTERIAL HAND SANITIZER) GEL [BRANDS INTERNATIONAL CORP]

ISLAND COTTON (ANTIBACTERIAL HAND SANITIZER) GEL [BRANDS INTERNATIONAL CORP]
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NDC 50157-117-01
Set ID 3f8ed4b8-0b00-2ebb-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Brands International Corp
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active Ingredient - Ethyl Alcohol 62%

  • PURPOSE

    Purpose - Antiseptic

  • INDICATIONS & USAGE

    Use

    To decrease bacteria on the skin and clean hands
    Recommened for repeated use

  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from fire or flame

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If accidently swallowed, get medical help or contact a Poison Control Center right away

  • SAFE HANDLING WARNING

    Do not get into eyes

    If contact occurs, rinse thoroughly with water

  • ASK DOCTOR

    Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor

  • DOSAGE & ADMINISTRATION

    Directions

    • apply to hands until thoroughly wet
    • rub vigorously until dry
    • supervise children in the use of this product
  • OTHER SAFETY INFORMATION

    Other Information

    • May discolour certain fabrics or surfaces
    • do not store above 110 F (43 C)
  • INACTIVE INGREDIENT

    Inactive Ingredients - Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annulus) seed extract, Blue 1 (Cl 42090)

  • PRINCIPAL DISPLAY PANEL

    Island Cotton Antibacterial Hand Sanitizer Gel

  • INGREDIENTS AND APPEARANCE
    ISLAND COTTON 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-117-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/02/2015
    Labeler - Brands International Corp (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corp243748238manufacture(50157-117)

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