Label: WET WIPES ANTIBACTERIAL HAND WIPES- benzethonium chloride swab

  • 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 May 6, 2020

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  • Active Ingredient

    Active Ingredient

    Benzethonium Chloride 0.3%

    Purpose

    Purpose Antimicrobial

  • Use

    Use

    Decrease bacteria on skin

  • Warnings

    For External use only

    Do not use

    Do not use if you are allergic to any of the ingredients

    When using this product

    ​When using this product do not get into eyes, if contact occurs rinse thoughly with water

    Stop use and ask a doctor

    Stop use and ask a doctor if irritation or rash develops and continues for more then 72 hours

    Keep out of reach of children

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

  • Directions

    Directions

    Adults and children 2 years and over

    • apply to hands
    • allow to dry without wiping
    • Children under 2 years ask a doctor before use
  • Other Information

    Other information

    • store at room temperature
    • may discolor certain fabrics
  • Inactive Ingredients

    Inactive Ingredients

    water, propylene gylcol, gylcerin, PEG-40 hydrogenated castor oil, disodium EDTA, aloe barbadnsis leaf juice, methylparaben, propylparaben

  • Package Label

    32 wipes NDC 77125-003-01 wet wipes label

  • INGREDIENTS AND APPEARANCE
    WET WIPES ANTIBACTERIAL HAND WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77125-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.45 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.0045 g  in 150 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.15 g  in 150 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.0165 g  in 150 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.0045 g  in 150 g
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.0045 g  in 150 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.15 g  in 150 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.15 g  in 150 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77125-003-01150 g in 1 BAG; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - Ningbo Yinzhou GreenLight International Trade Co.,Ltd (542990878)
    Registrant - NINGHAI WEIYI DAYLY NECESSITIES FACTORY (554532482)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Yinzhou Lvguang International Trade Co.,Ltd542990878repack(77125-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGHAI WEIYI DAYLY NECESSITIES FACTORY554532482manufacture(77125-003) , pack(77125-003) , label(77125-003)
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