Label: BENZALKONIUM CHLORIDE- sanitizing hand wipes cloth

  • NDC Code(s): 82355-550-01, 82355-550-02
  • Packager: ALO NEW YORK LLC
  • 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 November 29, 2022

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  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    • for hand sanitizing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only.

    Do not use

    if you are allergic to any of these ingredients.

    When using this product

    avoid contact with eyes. In case of contact, flush eyes with water.

    Stop use and ask a doctor

    if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of the reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • adults and children 2 years and over: apply to hands: allow to dry without wiping
    • children under 2 years: ask a doctor before use.
    • To dispense: Peel back fron label slowly. Remove wipes.
    • To reseal: Firmly rub thumb over label. Dispose of wipe in trash. Do not flush.
  • Other information

    store below 95

    • store below 95°F (35°C).
    • keep closed tightly
    • may discolor certain fabrics or surfaces.

  • Inactive ingredients

    Purified Water, Decyl Glucoside, Aloe Barbadensis (Aloe) Leaf Extract, Phenoxyethanol, Citric Acid, Sodium Benzoate, Potassium Sorbate, Eucalyptus Globulus Oil, Mentha Piperita (Peppermint) Oil.

  • Principal Display Panel

    ALO

    20 Skin-Softening Sanitizing Hand Wipes

    20 Count Wipes

    ALO

    20 Individually Wrapped Sanitizing Hand Wipes

    20 Individually Wrapped Wipes

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    sanitizing hand wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82355-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82355-550-0220 in 1 PACKAGE12/21/2021
    11 mg in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:82355-550-0120 in 1 PACKAGE12/21/2021
    21 mg in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/21/2021
    Labeler - ALO NEW YORK LLC (110122374)
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