Label: COOL BREEZE HAND SANITIZER- 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 May 19, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 68%

  • Purpose

     Antiseptic

  • Use

    For hand sanitizing

  • 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.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

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

  • Directions

    Wet hands thoroughly with product and rub hands together briskly until dry.

  • Inactive ingredients

    Glycerin,Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium Edta, Tocopheryl Acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    COOL BREEZE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-004
    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
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75613-004-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    2NDC:75613-004-0210 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/19/2020
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-004)
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