Label: ONE FOR ALL HAND SANITIZER- benzalkonium chloride liquid

  • 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 September 1, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic/Antimicrobial

  • Uses

    • For personal hand sanitizing to reduce viruses and bacteria on the skin.

    • Recommended for repeated use.

  • Warnings

    For external use only.

    Do not use in eyes or mouth. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if skin or eye irritation develop.

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

  • Directions

    • Dispense 1–2 pumps of foam.
    • Wet all surfaces of hands thoroughly.
    • Rub gently for 15 seconds until dry.

  • Other Information

    • Store below 110°F (43°C).
    • Avoid freezing or excessive heat above 104°F (40°C).

  • Inactive Ingredients

    USP Water, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Mentha Piperita (Peppermint) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Caffeic Acid, N1-Hexadecyl-N1,N1,N2,N2-Tetramethyl-N2-(3-(Trihydroxysilyl)Propyl)ethane-1,2-Diaminium Dichloride, N1,N1,N2,N2-Tetramethyl-N1-Octadecyl-N2-(3-(Trihydroxysilyl)Propyl)ethane-1,2-Diaminium Dichloride, Octadecyl-dimethyl (3-Trihydroxysilyl Propyl) ammonium chloride, Citric Acid, Urea.

  • Questions

    1-800-896-8092 | Mon-Fri 9 am – 5 pm PST

  • SPL UNCLASSIFIED SECTION

    Long-Lasting Nanodex™ Protection

    Kills > 99.99% of Germs in Seconds

    Gentle on Skin

    Made in USA

    We're putting science to work for the greater good.

    Designed by a team of doctors and scientists to give you the best possible health advantage at home, at work...and everywhere you go.

    Forms a long-lasting germicidal barrier that remains effective between hand-washings.

    • FDA-compliant for Consumer & Health Care use

    • With rejuvenating Vitamins C and E + Essential Oils

    • Leaves hands feeling smooth and moisturized

    • No alcohol, non-flammable

    • No perfumes, sulfates or parabens

    • No animal testing

    Manufactured for: ACatechol, Inc.

    10040 W Cheyenne Ave., Ste 170-65

    Las Vegas NV 89129

    OneForAllHands.com

  • Packaging

    One4all

  • INGREDIENTS AND APPEARANCE
    ONE FOR ALL HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80287-013
    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
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CAFFEIC ACID (UNII: U2S3A33KVM)  
    N1-HEXADECYL-N1,N1,N2,N2-TETRAMETHYL-N2-(3-(TRIHYDROXYSILYL)PROPYL)ETHANE-1,2-DIAMINIUM DICHLORIDE (UNII: 58T3X2WUB9)  
    N1,N1,N2,N2-TETRAMETHYL-N1-OCTADECYL-N2-(3-(TRIHYDROXYSILYL)PROPYL)ETHANE-1,2-DIAMINIUM DICHLORIDE (UNII: J4M68H8PMN)  
    OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80287-013-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    2NDC:80287-013-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    3NDC:80287-013-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/28/2020
    Labeler - Acatechol, Inc. (104141956)