Label: COVEX ANTIBACTERIAL BAR COOL PROTECTION- benzalkonium chloride soap

  • 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 March 1, 2021

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  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    When using this product

    Do not use

    • in the eyes.

    Stop use and ask a doctor if

    irritation and redness develop. 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 and forearms. Apply to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and repeat

  • Inactive ingredients:

    Sodium Tallowate, Sodium Palmate, Water, Sodium Palm Kernelate, Fragrance, Sodium Chloride, Glycerine, Zinc Oxide, C12-15 Alkyl Lactate, Titanium Dioxide, Tetrasodium EDTA, Etidronic Acid, Disodium Distyrylbiphenyl Disulfonate, Linalool, Limonene, Geraniol, Citral.

  • Package Labeling:51209-022-90

    Protection

  • Package Labeling:51209-022-27

    Protection2

  • INGREDIENTS AND APPEARANCE
    COVEX ANTIBACTERIAL BAR COOL PROTECTION 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    DISODIUM DISTYRYLBIPHENYL DISULFONATE (UNII: 81G7704MYR)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-022-9090 g in 1 BOX; Type 0: Not a Combination Product02/24/2021
    2NDC:51209-022-27270 g in 1 PACKAGE; Type 0: Not a Combination Product02/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/24/2021
    Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)
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