Label: BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY- 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 October 20, 2020

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  • beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vannilla

    beauty concepts ANTIBACTERIAL HAND WIPES Coconut Vannilla

    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 thoroughly with water

    Stop use and ask a doctor if irritation or rash occurs. This 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 into waste basket. Do not flush.

  • Inactive ingredients

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

  • beauty concepts ANTIBACTERIAL HAND WIPES Honey Almond

    beauty concepts ANTIBACTERIAL HAND WIPES Honey Almond

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose:

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    ■ To decrease bacteria on hands

  • Warnings

    For external use only

  • WHEN USING

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

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

  • KEEP OUT OF REACH OF CHILDREN

    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 into waste basket. Do not flush.

  • Inactive Ingredients

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

  • beauty concepts ANTIBACTERIAL HAND WIPES Sugar Berry

    beauty concepts ANTIBACTERIAL HAND WIPES Sugar Berry

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    ■ To decrease bacteria on hands

  • Warnings

    For external use only

  • WHEN USING

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

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

  • KEEP OUT OF REACH OF CHILDREN

    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 into waste basket. Do not flush.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA HONEY ALMOND SUGAR BERRY 
    benzalkonium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-354
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-354-011 in 1 KIT10/20/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 20 
    Part 21 PACKET 20 
    Part 31 PACKET 20 
    Part 1 of 3
    BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES COCONUT VANILLA 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-351
    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:50563-351-0120 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 finalpart333A10/20/2020
    Part 2 of 3
    BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES HONEY ALMOND 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-352
    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:50563-352-0120 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 finalpart333A10/20/2020
    Part 3 of 3
    BEAUTY CONCEPTS ANTIBACTERIAL HAND WIPES SUGAR BERRY 
    benzalkonium chloride solution
    Product Information
    Item Code (Source)NDC:50563-353
    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:50563-353-0120 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 finalpart333A10/20/2020
    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(50563-354)
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