Label: OCEAN BREEZE- ethyl 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 November 13, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, Peg-12 dimethicone, propylene glycol,

    tocopheryl acetate, triethanolamine, water

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 68% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • WARNINGS

    Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

    right away

  • INDICATIONS & USAGE

    Uses

    hand sanitizer to help reduce bacteria on skin

  • DOSAGE & ADMINISTRATION

    Directions - Put a dime sized

    drop onto hands and rub together briskly

    until dry.

  • DO NOT USE

    Do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

  • OTHER SAFETY INFORMATION

    Flammable. Keep away

    from fire or flame

  • STORAGE AND HANDLING

    Other Information.

    Store below 110 F (43C)

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    OCEAN BREEZE  
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-007-0129 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2013
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-007)
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