Label: ANTIBACTERIAL WIPES- benzalkonium 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 November 29, 2022

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

    Do not use if

    you are allergic to any of this product

    When using this product

    avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor

    If irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and Children 2 years and over: apply to hands and face. Allow to dry without wiping.

    Children under 2 years: ask a doctor before use

    To dispense: pull tab and remove large cover. Insert triangular threading loop through slits in cover. Do not push finger through the opening. Thread first sheet in center or roll through loop. Replace cover. Pull loop back through opening. Pull each sheet up and slightly to the side. Dispose of wipe in trash. Do not flush.

  • Other information

    Store below 95 o​F (35 oC). keep closed tightly. May discolor certain fabric or surfaces

  • Inactive ingredients

    Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA,  Citric Acid, Aloe Barbadensis  (Aloe)  Leaf Extract, Fragrance.

  • Principal Display Panel

    NDC 71293-020-01

    2000 count

    ERC

    ERC WIPING PRODUCTS

    KILLS 99.9% OF GERMS

    ANTIBACTERIAL WIPES

    Cleans, Disinfects and Deodorizes

    2000 Wipes per roll

    • safe on equipment
    • safe on hands
    • presaturated
    • made in USA

    ercwipe.com 800-225-9473

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71293-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71293-020-012000 in 1 BAG03/16/2017
    11 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/16/2017
    Labeler - ERC Acquisition, Inc (019312339)
    Registrant - ERC Acquisition, Inc (019312339)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precare Corp.117111327manufacture(71293-020)
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