Label: COVEX ANTIBACTERIAL BAR ACTIVE 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 January 27, 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 Contrl Center right away.

  • Directions

    • Wet hands and forearms. Apply to hands and foreams. Scrub thoroughly for 60 seconds. Rinse and repeat
  • Inactive ingredients:

    Sodium Tallowate, Sodium palmate, Water, Sodium Palm Kernelate, Fragrance, Sodium Chloride, Glycerin, C 12-15 Alkyl Lactate, Titanium Dioxide, Tetrasodium EDTA, Etidronic Acid, Disodium Distrylbiphenyl Disulfonate, Limonene, Linalool, Hexyl Cinnamal, Benzyl Salicylate, geraniol, Eugenol.

  • Package Labeling:

    Updated Active Box LabelUpdated Active wrapper packaging

  • INGREDIENTS AND APPEARANCE
    COVEX ANTIBACTERIAL BAR ACTIVE PROTECTION 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51209-017
    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 TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    DISODIUM DISTYRYLBIPHENYL DISULFONATE (UNII: 81G7704MYR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    GERANIOL (UNII: L837108USY)  
    EUGENOL (UNII: 3T8H1794QW)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51209-017-003 in 1 PACKAGE06/24/2020
    1115 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/23/2020
    Labeler - DALAN KIMYA ENDUSTRI ANONIM SIRKETI (566219285)
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