Label: SANI-COM PRE-MOISTENED, MULTI-PURPOSE CLEANING TOWEL- benzalkonium chloride cloth

  • NDC Code(s): 71489-005-01
  • Packager: Celeste Industries Corporation
  • 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 September 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

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

    For external use only

    When using this product avoid contact with eyes. In case of eye 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to hands
    • allow skin to dry without wiping
  • Inactive ingredients

    Water, Ethyl Alcohol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Linear alcohol ethoxylate, Fragrance

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Celeste Industries Corporation
    Easton, Maryland 21601 ∙ USA

  • PRINCIPAL DISPLAY PANEL - 1.75 mL Packet

    SANI-COM
    3205
    Pre-moistened, multi-
    purpose cleaning towel
    1.75 mL

    Antibacterial Hand Sanitizer Kills 99.999% of germs

    Phone ▪ Computer ▪ Communications Equipment
    Open packet ∙ Unfold cloth ∙ Wipe Surfaces

    PRINCIPAL DISPLAY PANEL - 1.75 mL Packet
  • INGREDIENTS AND APPEARANCE
    SANI-COM  PRE-MOISTENED, MULTI-PURPOSE CLEANING TOWEL
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71489-005
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71489-005-011 in 1 POUCH; Type 0: Not a Combination Product07/21/201709/19/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/21/201709/19/2025
    Labeler - Celeste Industries Corporation (047795034)
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