SWIRLING LOLLIPOP (ANTIBACTERIAL HAND SANITIZER GEL) GEL [BRANDS INTERNATIONAL CORP]

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SWIRLING LOLLIPOP (ANTIBACTERIAL HAND SANITIZER GEL) GEL [BRANDS INTERNATIONAL CORP]
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NDC 50157-114-01
Set ID 2346dcb3-f1b9-6ba8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Brands International Corp
Generic Name
Product Class
Product Number
Application Number PART333A
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  • PACKAGE LABEL

    SWIRLING LOLLIPOP

    ANTIBACTERIAL

    Hand Sanitizer Gel

    Kills 99.99% of Germs

    1 FL OZ (29ml) product label

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Ethyl Alcohol 62%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Use

    • To decrease bacteria on the skin and clean hands.
    • Recommended 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 accidentally swallowed get medical help or contact a Poison Control Center right away.

  • WHEN USING

    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

    • may discolor certain fabrics or surfaces
    • do not store above 110ºF (43ºC)
  • INACTIVE INGREDIENT

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annuus) Seed Extract, Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

  • INGREDIENTS AND APPEARANCE
    SWIRLING LOLLIPOP 
    antibacterial hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-114
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-114-0129 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)11/02/2015
    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(50157-114)
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