Label: OCEAN BREEZE  - alcohol gel 

  • Label RSS
  • NDC Code(s): 58194-007-01
  • Packager: Shanghai Weierya Daily Chemicals Factory
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    carbomer 940, Peg-12 dimethicone, propylene glycol,

    tocopheryl acetate, triethanolamine, water

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 68% v/v

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  • PURPOSE

    Purpose

    Antimicrobial

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  • WARNINGS

    Warnings

    For external use only

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  • 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

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  • INDICATIONS & USAGE

    Uses

    hand sanitizer to help reduce bacteria on skin

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  • DOSAGE & ADMINISTRATION

    Directions - Put a dime sized

    drop onto hands and rub together briskly

    until dry.

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  • DO NOT USE

    Do not use in or near the eyes.

    In case of contact, rinse eyes thoroughly with water.

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  • OTHER SAFETY INFORMATION

    Flammable. Keep away

    from fire or flame

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  • STORAGE AND HANDLING

    Other Information.

    Store below 110 F (43C)

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  • INGREDIENTS AND APPEARANCE
    OCEAN BREEZE  
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58194-007
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 68 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    PEG-12 DIMETHICONE (300 CST)  
    PROPYLENE GLYCOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    TROLAMINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58194-007-01 29 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/01/2013
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai Weierya Daily Chemicals Factory 420359333 manufacture(58194-007)
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