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

  • For external use only

  • DO NOT USE

    Over large areas of the body 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 right 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.

  • STORAGE AND HANDLING

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

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

  • DOSAGE & ADMINISTRATION

    Dosage: Swab - Administration: Topical

  • SUMMARY OF SAFETY AND EFFECTIVENESS

    • Convenient

    Easy to use & carry anywhere!

    • Clean-up

    Use to wash up quickly when soap and water are not available.

    • Moisturize

    Contains soothing Aloe to help moisturize your skin and leave it feeling soft and smooth.

  • PRINCIPAL DISPLAY PANEL

    Front Panel

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52629-800
    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:52629-800-0316 in 1 BOX12/20/2018
    11 in 1 PACKAGE
    10.3 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 finalpart333E12/20/2018
    Labeler - HIGIENE + SALUD, S.A. DE C.V. (814608832)
    Registrant - HIGIENE + SALUD, S.A. DE C.V. (814608832)
    Establishment
    NameAddressID/FEIBusiness Operations
    HIGIENE + SALUD, S.A. DE C.V.814608832manufacture(52629-800) , pack(52629-800) , label(52629-800)
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