Label: WET WIPES 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 November 5, 2020

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  • Uses

    1.Hand sanitizer to help reducebacteria on the skin.
    2.For use when soap and water are not available.

  • WARNINGS

    For external use only. Flammable.Keep away from heat or flame.

  • DO NOT USE

    Do not use on open skin wounds.

    Do not use in children less than 2months of age.

  • WHEN USING

    When using this product, keep out of reach of eyes and mouth. In case of contact with eyes,rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor irritation or rash occours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    1.open resealable label and pull one sheet from pack.
    2.Thoroughly clean hands or affected area and discard in receptacle.Do not flush.
    3.Allow to dry without wiping.
    4.Be sure to reseal label completely to retain moisture.

  • Other Information

    Store at room temperature.

  • INACTIVE INGREDIENT

    Water,Benzethonium chloride,Cetylpyridinium chloride anhydrous, Chlorphenesin,Propylene glycol,Phenoxyethanol,Ethylhexylglycerin, Pyrithione Sodium

  • ACTIVE INGREDIENT

    Benzethonium chloride

  • PURPOSE

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54156-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.03 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PYRITHIONE SODIUM (UNII: 6L3991491R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54156-001-0120 in 1 PACKET11/05/2020
    10.03 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/05/2020
    Labeler - Shandong Tricol Marine Biological Technology Co.,Ltd (541569370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Tricol Marine Biological Technology Co.,Ltd541569370manufacture(54156-001)
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