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 January 29, 2021

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  • Active Ingredient(s)

    Benzethonium chloride 0.03% （w/w）

  • Purpose

    Antiseptic

  • Use

    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 heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Tear the packaging at the zigzag edge to use

  • Other information

    • Store at room temperature
  • Inactive ingredients

    Water,Cetylpyridinium chloride anhydrous,Chlorphenesin,Propylene glycol,Phenoxyethanol,Ethylhexylglycerin,Phrithione Sodium

  • Package Label - Principal Display Panel

    package label

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54156-002
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PYRITHIONE SODIUM (UNII: 6L3991491R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54156-002-0124 in 1 PACKET11/20/2020
    10.03 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:54156-002-0220 in 1 PACKET11/20/2020
    20.03 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:54156-002-0310 in 1 PACKET11/20/2020
    30.03 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:54156-002-0448 in 1 PACKET11/20/2020
    40.03 g in 1 PATCH; Type 0: Not a Combination Product
    5NDC:54156-002-0596 in 1 PACKET11/20/2020
    50.03 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 finalpart333E11/20/2020
    Labeler - Shandong Tricol Marine Biological Technology Co.,Ltd (541569370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Tricol Marine Biological Technology Co.,Ltd541569370manufacture(54156-002)
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