Label: ICEE STRAWBERRY SCENTED HAND SANITIZER- alcohol liquid

  • 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 October 7, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient      Ethyl Alcohol     62%

  • PURPOSE



    Purpose                      Antiseptic
  • INDICATIONS & USAGE



    Uses:

    To decrease bacteria on skin that could cause disease

    Recommended for repeated use
  • WARNINGS


    Warnings:

    For external use only

    Flammable. Keep away from heat and flame.

    When using this product

        * Keep out of eyes.  In case of contact with eyes, flush thoroughly with water
        * Avoid contact with broken skin
        * Do not inhale or ingest


  • STOP USE


    Stop use and ask a doctor if skin irritation develops
  • 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.
  • DOSAGE & ADMINISTRATION



    Directions:
    Wet hands thoroughly with product and allow to dry without wiping
    For children under 6, use only under adult supervision.
    Not recommended for infants
  • STORAGE AND HANDLING



    Other Information

        * Do not store above 105F
        * May discolor some fabrics
        * Harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Water, Sodium Lauryl Sulfate, Carbomer, Glycerin, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, Aloe and Vitamin E Microbeads. May Contain: FD and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

  • PRINCIPAL DISPLAY PANEL

    fronfront label

  • PRINCIPAL DISPLAY PANEL

    backback label

  • INGREDIENTS AND APPEARANCE
    ICEE STRAWBERRY SCENTED HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34460-6008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35.16 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.2 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.2 g  in 100 g
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.1 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.02 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.003 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.005 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.002 g  in 100 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.01 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34460-6008-145 g in 1 BOTTLE
    2NDC:34460-6008-290 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/07/2010
    Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetics Co., Ltd.529047234manufacture
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