Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride swab

  • 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 July 30, 2013

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

View All Sections
  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin
  • Warnings

    For external use only.
    Do not use over large areas of the body
    if you are allergic to any of the ingredients.
    When using this product do not get into eyes.
    If contact occurs, rinse thoroughly with water.
    Stop use and ask a doctor if irritation or rash
    develops and continues for more than 72 hours.
    Keep out of reach of children.
    If swallowed, get medical help or contact
    a Poison Control Center right away.

    Keep out of reach of children

    if swallowed
    get medical help or contact a Poison Control Center right away.

  • Directions

    For adults and children of 2 years and over use
    on hands and face to clean and refresh, allow
    skin to air dry.
    For children under 2 years ask a doctor before use.

  • INACTIVE INGREDIENT

    water, propylene glycol,
    cocamidopropyl betaine, poly(hexamethyleneguanidine)
    hydrochloride, glycine, tetrasodium EDTA,
    aloe barbadensis leaf extract, tocopheryl acetate, citric acid,
    fragrance, methylchloroisothiazolinone, methylisothiazolinone,
    PEG-40 hydrogenated castor oil.

  • PRINCIPAL DISPLAY PANEL

    40.jpg

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59575-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCINE (UNII: TE7660XO1C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Water (UNII: 059QF0KO0R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59575-500-0140 in 1 PACKAGE
    13 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2013
    Labeler - Hebei Yihoucheng Commodity Co.,Ltd. (529305333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Yihoucheng Commodity Co.,Ltd.529305333manufacture(59575-500)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!