Label: BODY PRESCRIPTIONS APPLE CIDER INFUSED WITH VITAMIN E ANTIBACTERIAL HAND- benzalkonium chloride lotion

  • 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 March 27, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    ■ To help reduce the bacteria on the skin

  • WARNINGS

    For external use only

    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. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

  • Directions

    Apply a small amount to palm and rub hands together thoroughly

  • Other Information

    Do not store above 105F

    May doscolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate,  Phenoxyethanol, Polyacrylamide, Benzyl Alcohol, Fragrance (Parfum), C13-14 Isoparaffin, Laureth-7, Benoic Acid, Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Blue 1, Yellow 5

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS APPLE CIDER INFUSED WITH VITAMIN E ANTIBACTERIAL HAND 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-427
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-427-01236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2021
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-427)
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