Label: MOIST WIPES- benzalkonium chloride lotion

  • Category: HUMAN OTC DRUG LABEL

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 15, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium chloride 0.1%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Use   decreases bacteria on skin

  • WARNINGS

    Warnings

    For external use only

    Do not use

    -over large areas of the body

    -if you are allergic to any of the ingredients

    When using this product avoid contact with eyes and face.

    If contact occurs, flush thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and

    continues for more than 72 hours

  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    -for adults and children of 2 years and over

    -children under 2 years ask a doctor before using

    -allow to dry without wiping

  • STORAGE AND HANDLING

    Other information  store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredient

    Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barabdensis

    Leaf Extract, Polyaminopropyl Biguianide, Disodium EDTA,

    Fragrance, 2-Bromo-2 Nitroporpane 1,3 Diol, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MOIST WIPES 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55310-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55310-002-0220 in 1 BAG06/15/2016
    1NDC:55310-002-01.1 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2016
    Labeler - Shanghai Yinjing Medical Supplies Co., Ltd. (530501535)
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