Label: ANTISEPTIC HAND WIPES- polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab

  • NDC Code(s): 78724-008-01
  • Packager: Jiebao Daily Chemical (Xiangxi)Co.,Ltd
  • 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 July 31, 2020

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  • Active Ingredient

    POLYAMINOPROPYL BIGUANIDE 1.5%

    BENZALKONIUM CHLORIDE 0.2%

    CETYLPYRIDINIUM CHLORIDE 0.1%

    Purpose

    Antiseptic

  • USE

    • For hand and skin cleaning
    • Recommended for repeated use
    • For use when soap and water are not available
  • Warning

    • For external use only.
    • When using this product, Do not use into eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor, if irritation and redness develops; Condition persists for more than 72 hours
    • Do not use In children less than 2 months of age; On open skin wounds.

    Other Information：

    use in well ventilated areas; keep away from heat/sparks//open flames/hot surfaces

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing.
  • Inactive ingredients

    citric acid, disodium EDTA, Lauryl Pyridinium chloride, water

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND WIPES 
    polyaminopropyl biguanide, benzalkonium and cetylpyridinium swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78724-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET) POLYAMINOPROPYL BIGUANIDE15 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 1 g
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78724-008-0180 in 1 BAG07/31/2020
    14.70 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/04/2020
    Labeler - Jiebao Daily Chemical (Xiangxi)Co.,Ltd (405235017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiebao Daily Chemical (Xiangxi)Co.,Ltd405235017manufacture(78724-008)
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