Label: BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE- 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 30, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    ■ For hand washing to decrease bacteria on hands

  • WARNINGS

    For external use only - hands

    When Using this Product

    Keep out of eyes. In case of contact with eyes, flush thoroughly with water

    Stop use and ask a doctor if skin irritation develops. 

    keep out of reach of children

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

  • Directions

    Apply a small amount to hands. Lather for at least 20 seconds then rinse with warm water

    Avoid contact with eyes

    Not recommended for infants

  • Other Information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, Cocamidopropyl Betaine, PEG-150 Distearate, Cocamide MEA, Benzyl Alcohol, Fragrance, Phenoxyethanol, Sodium
    Hydroxide, Mentha Arvensis Extract, Melaleuca Alternifolia (Tea Tree) Extract, Benzoic Acid, Blue 1, Yellow 5

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND WASH MINT AND TEA TREE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
    MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-235-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Chengda Industrial Co., Ltd540042034manufacture(50563-235)
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