Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 

  • Label RSS
  • NDC Code(s): 50672-838-01
  • Packager: MC Group Development Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzalkonium Chloride

    Purpose

    Antibacterial
    Close
  • Use

    For hand washing to decrease bacteria on the skin.May be used on face,arms and legs.

    Close
  • WARNINGS

    For External use only.
    Keep out of eyes,Incase of contact,rinse with water.If irritation or rash develops,discontinue use .Consult doctor if irritation persists for more than 72 hours,If swallowed,seek medical attention or contact a Poison Control Center.

    keep out of reach of children

    keep out of reach of children

    Close
  • Directions

    Open resealable label.Pull one sheet from pack.Clean hands or affected area and discard.Re-seal label after each use to keep wipes fresh.

    Close
  • Inactive ingredients

    Iodopropynyl Butylcarbamate,DMDM Hydantoin,Lauryl Glucoside,Glycerin,D-Panthenol,Tocopheryl Acetate,Chamomilla Recutita Extract,PEG-12 Dimethicone,Disodium EDTA,Aloe Barbadensis Leaf Extract,Allantoin,Water

    Close
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50672-838
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Iodopropynyl Butylcarbamate  
    DMDM Hydantoin  
    Lauryl Glucoside  
    GLYCERIN  
    DEXPANTHENOL  
    TOCOPHERYL NICOTINATE, D-.ALPHA.  
    MATRICARIA RECUTITA  
    PEG-12 DIMETHICONE (300 CST)  
    DISODIUM EDTA-COPPER  
    ALOE VERA LEAF  
    Allantoin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50672-838-01 3.3 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/12/2012
    Labeler - MC Group Development Ltd. (527868588)
    Establishment
    Name Address ID/FEI Business Operations
    MC Group Development Ltd. 527868588 manufacture(50672-838)
    Close