Label: BREEZE HAND SANITIZER WITH VITAMIN E AND ALOE VERA- ethyl alcohol gel

  • NDC Code(s): 74955-020-17, 74955-020-18, 74955-020-33, 74955-020-84
  • 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 June 5, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses • Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

    Stop use and ask a doctor. If irritation or rashes appears and lasts.

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

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using BREEZE.

  • Other Information

    • Store below 100°F (38°C)
    • May discolour certain fabrics or surfaces.

  • Inactive ingredients

    Aqua, Polyquaternium-37, Aloe Barbadensis Leaf Juice (Aloevera), Tocopheryl Acetate(Vit E), Parfume, Citral, Butylphenyl Methylpropional, D-Limonene.

  • SPL UNCLASSIFIED SECTION

    Extra Soft

    Vit E & ALOE VERA

    REFRESHING GEL

    Kills More than 99.9% of Germs Without Water

    *Kills 99.9% of most common germs that may cause illness

    COSMOLIVE KOZMETIK SAN. TIC. A. S.

    10022 Sok No: 4 A.O.S.B. Cigli- Izmir -Turkiye

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

    USA DISTRIBUTOR: UNAC INTERNATIONAL INC. 

    info@unacusa.com

    Made in TURKEY 

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    BREEZE HAND SANITIZER WITH VITAMIN E AND ALOE VERA 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74955-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SULFURYL FLUORIDE (UNII: 64B59K7U6Q)  
    CITRAL (UNII: T7EU0O9VPP)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74955-020-17500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:74955-020-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/10/2020
    3NDC:74955-020-33100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
    4NDC:74955-020-1855 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2020
    Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(74955-020)
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