Label: SWET PROTECT- benzalkonium chloride solution

  • Category: HUMAN OTC DRUG LABEL

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 October 12, 2020

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  • ------

    *Effective at eliminating 99.9% of most common germs that may cause illness.

  • Drug Facts

  • Active Ingredient & Purpose

    Active ingredientPurpose
    Benzalkonium Chloride 0.13% v/v..........................................................................................................................................Antiseptic

    Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Do not use

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

    When using this product

    When using this product keep out of eyes. 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.

  • Directions

    • place enough product on hands to cover all surfaces. Rub hands together until dry.
    • supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • store between 68-77˚F (20-25˚C)
    • do not expose to excessive heat

    TAMPER EVIDENT: Do not use if the sealable tab is open or torn.

  • Inactive ingredients

    allantoin, benzyl alcohol, edetate sodium, fragrance, glycerin, phenoxyethanol, polyoxyl 40 hydrogenated castor oil, propylene glycol, sodium hydroxide, trisodium nitrilotriacetate, water

  • Questions or comments?

    +1-844-512 4626 (M-F) 9AM to 5 PM CDT or www.s-wet.com.mx

  • Package Label - Principal Display Panel

    Kills 99.9% of Germs*

    15 Wipes

    7.08 in x 4.72 in (18 cm x 12 cm)

    NDC 79827-101-15

    Wipe 15

  • INGREDIENTS AND APPEARANCE
    SWET PROTECT 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79827-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.4336 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    2-METHYL-2-METHYLAMINO-1-PROPANOL (UNII: UHE79J5KHU)  
    HONEY (UNII: Y9H1V576FH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    OAT (UNII: Z6J799EAJK)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79827-101-1215 in 1 BAG; Type 0: Not a Combination Product10/12/2020
    2NDC:79827-101-20140 in 1 CANISTER; Type 0: Not a Combination Product10/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Energía 5 Mas 1 Comercio, S.A. de C.V. (814860128)
    Registrant - L Squared Global (117528076)
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