Label: GLITTER RITZ ICED BERRY- alcohol gel

  • 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 April 17, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                                     Purpose

    Alcohol denat. 63% .................................. Antiseptic

  • PURPOSE

    Uses

    to decrease bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Hand Sanitizer

    30 ml 1.0 fl.oz.

  • WARNINGS

    Warnings

    For external use only.

    Flammable.

    Keep away from heat and flame.

    When using this product

    • Avoid contact with eyes. If contact occurs, flush eyes with water.
    • Avoid contact with broken skin.

    Stop use and ask a doctor if

    irritation and redness develop and persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands with product and allow to dry without wiping.
    • Not recommended for infants.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    alcohol denat., water, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, fragrance, lactose, cellulose, hydroxypropyl methylcellulose, jojoba esters, tocopheryl acetate, yellow 5 (CI 19140), red 4 (CI 14700)

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    GLITTER RITZ ICED BERRY 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    LACTOSE (UNII: J2B2A4N98G)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-512-0163 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/15/2015
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-512)
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