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

  • 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 August 13, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.20%

  • Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Use • For handwashing to decrease bacteria on the skin

  • WARNINGS

    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 develop.

    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, Cocoamidopropyl Betaine, Coco Glucoside, Glyceryl Oleate, Cocoamide DEA, Sodium Laureth Sulphate, Laureth-7 Citrate, Tocopheryl Acetate (Vit E), Sodium Chloride, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Fragrance, Coumarin, Hexyl Cinnamal, Hydroxycitronellal, D-Limonene, Linalool, CI 42090, CI 19140

  • SPL UNCLASSIFIED SECTION

    Extra Soft

    CLEANSING

    MOISTURIZING

    REFRESHING

    UNAC GROUP KOZMETIK SAN. TIC LTD. STI

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

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

    Made in TURKEY

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BREEZE ANTIBACTERIAL HANDSOAP CHAMOMILE ALOE VERA 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74955-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    LAURETH-7 (UNII: Z95S6G8201)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74955-025-03500 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 finalpart333A08/03/2020
    Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(74955-025)
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