Label: BREEZE ANTIBACTERIAL 150 ML- alcohol spray

  • 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 20, 2020

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  • Drug Facts

  • Active Ingredient

    Ethanol 85%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use ​​• Helps decrease bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    • Avoid contact with eyes. In case of eye contact, rinse with water.
    • If irritation develops, discontinue use. Consult a doctor if irritation persists more than 72 hours.
    • Store in cool and dry place.

    • Keep out of reach of children
  • Directions for use

    • Hold the container 15 cm away.
    • Spray directly on hands and rub in thoroughly. Allow to dry.
    • Children under 6 years of age should be supervised when using BREEZE.
  • Other Information

    • Store between 68°F (20°C).
    • May discolor certain fabrics and surfaces.
  • Inactive Ingredients

    • Butane, Aqua, Propane, Isobutane, Propylene Glycol, Isopropyl Myristate, Parfum, Benzalkonium Chloride.
  • SPL UNCLASSIFIED SECTION

    Hand Cleaning SPRAY +

    ANTIBACTERIAL Hand Sanitizer

    ANTIBACTERIAL CARE

    Antibacterial Care Hand Sanitizer

    kills 99.99% of Bacteria and Germs

    COSMOLIVE KOZMETIK SAN. TIC. A.S.

    10022 Sok. No:4 A.O.S.B. Çiğli-İzmir-Türkiye

    www.cosmolive.com.tr - info@cosmolive.com.tr

    USA DISTRIBUTOR: UNAC INTERNATIONAL INC.

    info@unacusa.com

    Made in TURKEY

    EAC

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BREEZE ANTIBACTERIAL 150 ML 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74955-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    WATER (UNII: 059QF0KO0R)  
    PROPANE (UNII: T75W9911L6)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74955-022-05150 mL in 1 CAN; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2020
    Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(74955-022)
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