Label: ANTISEPTIC WIPES- alcohol, benzalkonium chloride cloth

  • 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 13, 2020

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  • ACTIVE INGREDIENTS

    Ethyl alcohol 15%. Purpose: Antiseptic

    Benzalkonium Chloride 0.1%. Purpose: Antiseptic

  • PURPOSE

    Antiseptic

  • WARNINGS

    • For external use only.
  • DO NOT USE

    on children less than three years old and on skin wounds.

  • WHEN USING THIS PRODUCT

    Keep out of eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

  • STOP USE AND ASK A DOCTOR IF

    irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • Open lid, gently pull back resealable label, remove and use wipe as required.
    • Reseal back after use to avoid evaporation of alcohol.
    • Discard after single use. Required dispose of used wipe in trash receptable.
    • Do not flush.
  • USES

    • For hand washing to decrease bacteria on the skin.
    • Apply topically to the skin to help prevent cross contamination.
  • OTHER INFORMATION

    Store at room temperature, avoid sunlight irradiating.

  • INACTIVE INGREDIENTS

    Water, Cetylpyridinium chloride, Chlorphenesin, Biguanide, Propylene glycol

  • INGREDIENTS AND APPEARANCE

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    72 PCS NDC: 80168-001-01

    D&A USA

    CONTAINS

    75% ALCOHOL STOSTE

    ANTISEPTIC WIPES

    for hand cleaning

    72 Wipes

    7.87 x 5.51 in (20 x 14 cm)

    package label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC WIPES 
    alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80168-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BIGUANIDE (UNII: FB4Q52I9K2)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80168-001-0172 in 1 BAG09/13/2020
    1320 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/13/2020
    Labeler - D&A USA, LLC (117661331)
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