Label: EVOWELL HAND SANITIZER WITH ALOE VERA- benzalkonium chloride liquid

  • 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 February 4, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial and First aid antiseptic

  • Uses

    For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

  • Directions

    Pump onto hands as needed. Rub briskly together until dry. Pump onto wounds 3 times a day after cleaning. Allow foam to dissipate. Wipe excess with sterile gauze. May be bandaged once dry.

  • Inactive ingredients

    ionized water, aloe vera, carbamide

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: EvoWell™ 10 Henderson Drive, West Caldwell, NJ 07006

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    EVOWELL™
    WELLNESS EVOLVED

    Hand Sanitizer
    with Aloe Vera

    EXTENDED PROTECTION*

    Eliminates 99.99% of Germs

    alcohol-free
    triclosan-free & fragrance-free

    Non-Irritating • Non-Stinging

    Benzalkonium Chloride 0.13%

    Antimicrobial
    & Antiseptic

    2.0 FL OZ
    (59 mL)

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    EVOWELL HAND SANITIZER WITH ALOE VERA 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    urea (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74154-005-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A04/27/2020
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cemi International015038336MANUFACTURE(74154-005)
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