Label: ASSURED- 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 January 13, 2022

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.125%

  • PURPOSE

    Antibacterial

  • USE

    Decreases bacteria on skin.

  • For external use only

  • DO NOT USE

    If you are allergic to any of the ingredients

  • WHEN USING

    Do not get into eyes.

    If contact occurs, rinse thoroughly with water.

  • STOP USE

    If irritation or rash develops and continues for more than 72 hours

  • ASK DOCTOR

    If irritation or rash develops and continues for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    • Thoroughly wipe hands and face as desired.

    • Allow to dry without wiping.
    • Discard wipe in trash receptacle after use.
    • Do not flush.

  • INSTRUCTIONS FOR USE

    To dispense wipe: Peel back front label slowly. Remove wipes.

    To reseal pouch: Firmly run thumb over the label.

  • STORAGE AND HANDLING

    Store at room temperature. Cold weather may cloud this product. It's antiseptic properties are not affected.

  • INACTIVE INGREDIENT

    Water, Propylene Glycol, Polysorbate 20, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Vitamin E, Methylchloroisothiazolinone, Aloe Extract, Tetrasodium EDTA.

  • DOSAGE & ADMINISTRATION

    Dosage: Swab

    Administration: Topical

  • SUMMARY OF SAFETY AND EFFECTIVENESS

    Assured TM Antibacterial Wet Wipes kills germs and bacteria, cleans and freshens your skin and gently wipes away perspiration and odor.

    With moisturizing formula containing Aloe Vera and Vitamin E, Assured TM Antibacterial Wet Wipes are soft and gentle, and helping to nourish your skin as you freshen up.

    This travel pack is convenitent to take along for use anytime or anywhere.

    ASSURED
    Antibacterial
    Wet Wipes
    Hand & face moisturizing towelettes

    For hands and face
    Ideal for travling
    Moisturizing
    Thick and soft cloths
    Fresh scent

  • PRINCIPAL DISPLAY PANEL

    LABEL WATERFALLWATERFALLASSURED ANTIBACTERIAL WIPES 3X10

    ANTIBACTERIAL 15 COUNT

    INNER ANIBACTERIAL 15 COUNT

    ANTIBACTERIAL 20 COUNT

    ANTIBACTERIAL 40 COUNT

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70697-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 98.54 mg  in 100 mg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 mg  in 100 mg
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.3 mg  in 100 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.01 mg  in 100 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 mg  in 100 mg
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) 0.2 mg  in 100 mg
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 mg  in 100 mg
    EDETATE SODIUM (UNII: MP1J8420LU) 0.03 mg  in 100 mg
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.018 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70697-800-033 in 1 BAG06/10/2016
    110 in 1 PACKAGE
    13 mg in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70697-800-0440 in 1 PACKAGE06/10/2016
    20.375 mg in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70697-800-0520 in 1 PACKAGE06/10/2016
    30.375 mg in 1 POUCH; Type 0: Not a Combination Product
    4NDC:70697-800-062 in 1 PACKAGE06/10/2016
    415 in 1 PACKAGE
    42 mg in 1 POUCH; Type 0: Not a Combination Product
    5NDC:70697-800-0712 in 1 CASE06/10/2016
    5103.2 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/10/2016
    Labeler - INDELPA, S.A. DE C.V. (811072487)
    Registrant - INDELPA, S.A. DE C.V. (811072487)
    Establishment
    NameAddressID/FEIBusiness Operations
    INDELPA, S.A. DE C.V.811072487manufacture(70697-800) , analysis(70697-800) , pack(70697-800) , label(70697-800)
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