Label: BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA- benzalkonium chloride liquid

  • NDC Code(s): 74955-032-01
  • Packager: COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • 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 October 21, 2020

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    • For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    When using this product • Avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pump into hands, wet as needed

    • Lather vigorously for at least 15 seconds

    • Wash skin, rinse thoroughly and dry

  • Inactive ingredients

    Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Yellow No:5, FD&C Blue No.1, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.

  • SPL UNCLASSIFIED SECTION

    Extra Soft

    CLEANSING

    MOISTURIZING

    REFRESHING

    UNAC GROUP KOZMETİK SAN. TİC. LTD. ŞTİ.

    Trump Towers Residence No: 12/238 D.No:606 Şişli, Istanbul- TURKEY - Tel: +90 212 526 68 69 www.unac.com.tr

    USA DISTRIBUTOR: UNAC INTERNATIONAL INC. / info@unacusa.com

    Made in TURKEY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE AND ALOE VERA 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74955-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74955-032-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2020
    Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(74955-032)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!