Label: BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED- benzalkonium chloride kit

  • 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 14, 2020

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  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

    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 into waste basket. Do not flush.

  • Inactive ingredients

    Water, Glycerin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Fragrance

  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose:

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    ■ 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 into waste basket. Do not flush.

  • Inactive Ingredients

    Water, Glycerin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Fragrance

  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    ■ 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 into waste basket. Do not flush.

  • Inactive Ingredients

    Water, Glycerin, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Fragrance

  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES ALOE SCENTED

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  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES LEMON SCENTED

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  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND WIPES FRESH CITRUS SCENTED

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  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED LEMON SCENTED FRESH CITRUS SCENTED 
    benzalkonium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-224
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-224-011 in 1 KIT06/12/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 20 
    Part 21 PACKET 20 
    Part 31 PACKET 20 
    Part 1 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL WIPES ALOE SCENTED 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-221
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-221-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Part 2 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL WIPES LEMON SCENTED 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-222
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-222-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Part 3 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL WIPES FRESH CITRUS SCENTED 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-223
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-223-0120 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    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(50563-224, 50563-221, 50563-222, 50563-223)
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