Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED- benzalkonium chloride solution

  • 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 October 20, 2020

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

View All Sections
  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Use

    ■ To decrease bacteria on hands

  • WARNINGS

    For external use only

    When using this product, avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

  • Directions

    For adults and children two years and over

    Peel over reusable label and remove a wipe from the packet.

    Wet hands thoroughly and air dry. 

    Place used wipes in to waste basket.  Do not flush.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES CRANBERRY SCENTED 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-369
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE3.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-369-01100 in 1 PACKET; Type 0: Not a Combination Product10/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/20/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(50563-369)
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!