OCEAN BREEZE (ETHYL ALCOHOL) GEL [SHANGHAI WEIERYA DAILY CHEMICALS FACTORY]

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OCEAN BREEZE (ETHYL ALCOHOL) GEL [SHANGHAI WEIERYA DAILY CHEMICALS FACTORY]
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NDC 58194-007-01
Set ID f4a75cac-9528-4929-95f1-c8e570e3deff
Category HUMAN OTC DRUG LABEL
Packager Shanghai Weierya Daily Chemicals Factory
Generic Name
Product Class
Product Number
Application Number PART333A
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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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