Label: RUE21 OCEAN BREEZE ANTIBACTERIAL 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 July 9, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 63%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    To decrease bacteria on the skin

  • WARNINGS

    For external use only

    When using this product: Keep out of eyes. Do not inhale or ingest.

     


  • ASK DOCTOR

    Stop use and ask a doctor if skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime size drop into hands
  • STORAGE AND HANDLING

    Other Information:

    • Do not store above 105F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

  • PRINCIPAL DISPLAY PANEL

    lablabel

  • INGREDIENTS AND APPEARANCE
    RUE21 OCEAN BREEZE ANTIBACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 33.79985 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-139-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/09/2013
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Registrant - Zhejiang Aidi Cosmetics Co., Ltd. (530876820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Aidi Cosmetics Co., Ltd.530876820manufacture(50563-139)
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