DailyMed - DailyMed Details

SPL v1

SPL

SPL Set ID b0723781-225a-46c6-907c-5c5c48f383b8

Route

TOPICAL

Published

Effective Date 2025-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 mg)

Inactive Ingredients

Water Starch, Corn Avocado Oil Pectin Petrolatum Phenoxyethanol Xanthan Gum Potassium Sorbate Tri-n-butyl Phosphate Citrus Paradisi Seed Ethylhexylglycerin Tocopherol Glycerin Ascorbic Acid Bht Sodium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Benzalkonium chloride, 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium chloride, 0.13%

Uses

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

Warnings

For external use only: hands

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

Active Ingredient

Benzalkonium chloride, 0.13%

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

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

Durashield Hand Sanitizing Lotion 2 Fl Oz Ndc 85131 013 02

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

Durashield Hand Sanitizing Lotion 4 Fl Oz Ndc 85131 013 04

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

Durashield Hand Sanitizing Lotion 8 Fl Oz Ndc 85131 013 08

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

Durashield Hand Sanitizing Lotion 12 Fl Oz Ndc 85131 013 12

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

Durashield Hand Sanitizing Lotion 16 Fl Oz Ndc 85131 013 16

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

Durashield Hand Sanitizing Lotion 0.011 Fl Oz Ndc 85131 013 00

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

Structured Label Content

Uses

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

Purpose

Antimicrobial

Warnings

For external use only: hands

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

Active Ingredient (Active ingredient)

Benzalkonium chloride, 0.13%

Other Information (Other information)

Store between 35°-100°F

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

www.DuraShieldProtects.com

Tel: 1-855-NOT-ALC0 or 1-855-668-2520

When Using This Product (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 (Stop use and ask a doctor if)

irritation and redness develop
condition persists for more than 72 hours

Keep Out of Reach of Children (Keep out of reach of children)

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

Durashield Hand Sanitizing Lotion 2 Fl Oz Ndc 85131 013 02 (Durashield Hand Sanitizing Lotion 2 Fl Oz - NDC 85131-013-02)

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

Durashield Hand Sanitizing Lotion 4 Fl Oz Ndc 85131 013 04 (Durashield Hand Sanitizing Lotion 4 Fl Oz - NDC 85131-013-04)

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

Durashield Hand Sanitizing Lotion 8 Fl Oz Ndc 85131 013 08 (Durashield Hand Sanitizing Lotion 8 Fl Oz - NDC 85131-013-08)

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

Durashield Hand Sanitizing Lotion 12 Fl Oz Ndc 85131 013 12 (Durashield Hand Sanitizing Lotion 12 Fl Oz - NDC 85131-013-12)

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

Durashield Hand Sanitizing Lotion 16 Fl Oz Ndc 85131 013 16 (Durashield Hand Sanitizing Lotion 16 Fl Oz - NDC 85131-013-16)

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

Durashield Hand Sanitizing Lotion 0.011 Fl Oz Ndc 85131 013 00 (Durashield Hand Sanitizing Lotion 0.011 Fl Oz - NDC 85131-013-00)

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

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOCADO OIL", "unii": "6VNO72PFC1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PECTIN", "unii": "89NA02M4RX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRI-N-BUTYL PHOSPHATE", "unii": "95UAS8YAF5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRUS PARADISI SEED", "unii": "12F08874Y7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BHT", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to decrease bacteria on the skin that could cause disease recommended for repeated use", "Purpose": "Antimicrobial", "Warnings": "For external use only: hands", "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", "Active ingredient": "Benzalkonium chloride, 0.13%", "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", "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", "Durashield Hand Sanitizing Lotion 2 Fl Oz - NDC 85131-013-02": "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 ® 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 ® 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 ® 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 ® 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.", "Durashield Hand Sanitizing Lotion 0.011 Fl Oz - NDC 85131-013-00": "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:21.105107 · Updated: 2026-03-14T23:07:01.452935