Label: SNUGELL- benzalkonium chloride spray

  • 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 March 8, 2022

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13% (w/w)

  • Purpose

    Antiseptic

  • Uses

    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 
    • Near eyes or on open skin wounds

    When using this product ​avoid contacting with eyes. In case of eye contact, rinse eyes 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 at 800-222-1222.

  • Directions

    • Sprays over the desired skin surface area and rub thoroughly. No rinse is required.
    • Children under 6 years of age should be supervised when using this product.

  • Other Information

    • Avoid freezing and store below 110F (43C).
    • Dispose of the empty can in a recycling bin.

  • Inactive Ingredients

    Aloe barbadensis leaf extract, butylene glycol, chamomilla recutita (matricaria) extract, grape seed extract, purified water.

  • Questions or Comments?

    Call 1-844-451-6555

  • SPL UNCLASSIFIED SECTION

    Leaves No Chemical Residue

    Alcohol-Free

    Antiseptic Spray

    with Aloe Vera

    KILLS 99% OF GERMS AND BACTERIA

    Distributed by:
    Snugell, LLC
    Miami, FL 33015
    www.snugell.com

    MADE IN CHINA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SNUGELL 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80671-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80671-005-33473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2022
    Labeler - QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD (554548985)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD554548985manufacture(80671-005)
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