Label: DOC HYGIENE EXTRA STRENGTH SANITIZING WIPES- 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 August 25, 2020

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  • Drug Facts

  • Active Ingredient

    • Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin.

    • For use when soap and water are not available.

  • Warnings

    • For external use only.

    • Flammable, Keep away from source of heat or flame.

    • When using this product, keep out of eyes, ears, and mouth.

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

    • Stop use and ask a doctor if irritation or rash occurs. 

    • Do not use on open skin wounds.

    • Do not flush down toilet.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Open packet, remove and unfold pre-moistened tissue. Wipe hands or affected area thoroughly, then discard properly after use. Reseal back after use to keep wipes fresh.

  • Inactive Ingredients

    • Phenoxy Ethanol, Polyhexamethylene Biguanide Hydrochloride, Purified Water, Propylene Glycol, Ethyl Alcohol, Vitamin E, Lemon Terpenes, Aloe Vera Extract.

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    Lemon Scent

    ANTI-BACTERIAL

    SAFE & CLEAN

    MOISTURIZING WITH VITAMIN E & ALOE

    Distributed in the USA by DOC HYGIENE

    www.DocHygiene.com

    Questions or Comments?

    info@DocHygiene.com

    Made in China

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    DOC HYGIENE EXTRA STRENGTH SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79508-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LEMON TERPENES (UNII: 5DHA4TVW63)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79508-020-0110 in 1 PACKET08/25/2020
    15.94 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:79508-020-0235 in 1 CANISTER08/25/2020
    27.92 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - Blue Flame Medical Llc (117485880)
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