Label: COVEX ANTIBACTERIAL HAND SANITIZER, COOL BREEZE- 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 April 6, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol %60

    Purpose

    Antibacterial

  • Uses

    • To help reduce bacteria on hands
    • Recommended for repeated use
  • Warnings

    For external use only: Hands

    Flammable, keep away from fire of flame

    When using this product.

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin
    • Do not inhale or ingest

    Stop use and ask a doctor if

    - irritation and redness develop or if condition persists for more than 72 hours consult a doctor.

    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 allow to dry without wiping  - for children under 6, use only under adult supervision   - not recommended for infants.

  • Other information

    Do not store above 105°F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients:

    Water, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Sea Salt Extract, Amyl Cinnamal, Limonene, Linalool, Alpha-Isomethyl Ionone, Citral, Geraniol

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    COVEX ANTIBACTERIAL HAND SANITIZER, COOL BREEZE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    CITRAL (UNII: T7EU0O9VPP)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-012-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/03/2020
    Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)
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