Label: BODY PRESCRIPTIONS VITAMIN C TRAVEL PACK ANTIBACTERIAL HAND WIPES- 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 June 12, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Use

    ■ To decrease bacteria on hands

  • WARNINGS

    For external use only

    Stop Use

    Do not use if you are allergic to any ingredients listed

    Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

    Do not get into eyes. Rinse thoroughly with water if contact occurs

    keep out of reach of children

    Keep out of reach of children

  • 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

    Water, Glycerin, Ethylhexylglycerin, Ascorbic Acid, Phenoxyethanol, Propylene Glycol, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS VITAMIN C TRAVEL PACK ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE4.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-217-013 in 1 PACKAGE06/12/2020
    120 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(50563-217)
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