Label: HAND WIPES- chlorhexidine digluconate and benzethonium chloride cloth

  • NDC Code(s): 71734-203-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES 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 October 9, 2017

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Benzethonium Chloride  ..........  0.08

    Chlorhexidine Digluconate ........ 0.10

  • Purpose

    Cleaning

  • Uses:

    Cleans and refreshes hands and face without soap and water

  • WARNINGS

    For external use only.

    • for external use on hands only.
    • Stop use and sonsult a doctor if skin irritation develops.
    • Store in a cool place.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Self-dries in seconds. Leaves skin soft and smooth.

  • Inactive Ingredients:

    5-chloro-2-methyl-2H-isothiazol-3-one, Methylisothiazolinone, Polyaminopropyl Biguanide, Glycerol, Water

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    HAND WIPES 
    chlorhexidine digluconate and benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.1 g  in 1 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.08 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    Water (UNII: 059QF0KO0R)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-203-0113.3 g in 1 PACKAGE; Type 0: Not a Combination Product10/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/09/2017
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-203)
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