Label: DURASHIELD- benzalkonium chloride lotion

  • NDC Code(s): 85131-013-00, 85131-013-02, 85131-013-04, 85131-013-08, view more
    85131-013-12, 85131-013-16
  • Packager: Advanced Biomedical Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active ingredient

    Benzalkonium chloride, 0.13%

  • Purpose

    Antimicrobial

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not ingest

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • Apply a small amount of lotion into palm of hand
    • Rub hands together thoroughly until dry
    • No towels or wiping required
    • for children under 6, use only under adult supervision
  • Other information

    • Store between 35°-100°F
  • Inactive ingredients

    purified water (aqua), zea mays (corn) starch, persea gratissima (avocado) oil, pectin, petrolatum, phenoxyethanol, xanthan gum, potassium sorbate, tributyl phosphate, citrus paradisi (grapefruit) seed extract, ethylhexylglycerin, tocopherol, glycerin, ascorbic acid, bht, sodium hydroxide

  • Questions or comments?

    www.DuraShieldProtects.com
    Tel: 1-855-NOT-ALC0 or 1-855-668-2520

  • Durashield Hand Sanitizing Lotion 0.011 Fl Oz - NDC 85131-013-00

    durashield-0-011oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    0.011 FL OZ (0.33mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-00

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • Durashield Hand Sanitizing Lotion 2 Fl Oz - NDC 85131-013-02

    durashield-2oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    2 FL OZ (59mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-02

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • Durashield Hand Sanitizing Lotion 4 Fl Oz - NDC 85131-013-04

    durashield-4oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    4 FL OZ (118mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-04

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • Durashield Hand Sanitizing Lotion 8 Fl Oz - NDC 85131-013-08

    durashield-8oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    8 FL OZ (237mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-08

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • Durashield Hand Sanitizing Lotion 12 Fl Oz - NDC 85131-013-12

    durashield-12oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    12 FL OZ (355mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-12

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • Durashield Hand Sanitizing Lotion 16 Fl Oz - NDC 85131-013-16

    durashield-16oz

    DuraShield®

    Advanced Hand Sanitizing Lotion

    Moisturizing Vitamin E & Avocado Oil Formula

    Dermatologically Tested

    Safe on Skin

    Prolonged Protection

    Kills 99.99% of Germs*

    Made in the USA

    16 FL OZ (473mL)

    100% Fragrance Free

    100% Alcohol-Free

    100% Paraben-Free

    Clinically Tested

    Safe for all glove types

    • Latex
    • Vinyl
    • Nitrile

    *Kills 99.99% of most common germs that may cause illness.

    Puts The Power To Fight Germs In Your Hands™

    Alcohol-Free Hand Sanitizing Lotion

    NDC: 85131-013-16

    Distributed by: Advanced Biomedical, Inc. Frisco, TX 75035

    © 2025 Advanced Biomedical, Inc. All rights reserved.

  • INGREDIENTS AND APPEARANCE
    DURASHIELD 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85131-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PECTIN (UNII: 89NA02M4RX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BHT (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85131-013-000.33 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2024
    2NDC:85131-013-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2024
    3NDC:85131-013-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2024
    4NDC:85131-013-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2024
    5NDC:85131-013-12355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2024
    6NDC:85131-013-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/18/2024
    Labeler - Advanced Biomedical Incorporated (029084777)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc.624386772manufacture(85131-013)
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