93edc355-9bf4-40be-885f-020166cddbdb

SPL v4

SPL

SPL Set ID 93edc355-9bf4-40be-885f-020166cddbdb

Route

topical

Published

Effective Date 2021-02-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

water dihydroxyethyl cocamine oxide .gamma.-methacryloxypropyltrimethoxysilane

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2021-02-02

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only. Avoid contact with the eyes.

When using this product

Avoid contact with eyes. If contact occurs, flush eyes with water.

Stop use and consult doctorif irritation or redness develops or

persists for 72 hours.

Uses

Hand sanitizer to decrease pathogens on the skin

Recommended for repeated use

For use when soap and water are not available

Purpose

Antiseptic

Directions

Wet hands and work in thoroughly, allow to dry without wiping.

Other Information

Avoid freezing and excessive heat above 40°C.

Inactive Ingredients

Dihydroxyethyl Cocamine Oxiide (Surfactant), Purified Water, 3-(Trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.

Description

Benzalkonium Chloride 0.13%

Lable

Active Ingredient

Benzalkonium Chloride 0.13%

Keep Out of Reach of Children.

In case swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only. Avoid contact with the eyes.

When using this product

Avoid contact with eyes. If contact occurs, flush eyes with water.

Stop use and consult doctorif irritation or redness develops or

persists for 72 hours.

Uses

Hand sanitizer to decrease pathogens on the skin

Recommended for repeated use

For use when soap and water are not available

Purpose

Antiseptic

Directions

Wet hands and work in thoroughly, allow to dry without wiping.

Other Information

Avoid freezing and excessive heat above 40°C.

Inactive Ingredients

Dihydroxyethyl Cocamine Oxiide (Surfactant), Purified Water, 3-(Trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.

Lable

Active Ingredient

Benzalkonium Chloride 0.13%

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

In case swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIHYDROXYETHYL COCAMINE OXIDE", "unii": "8AR51R3BL5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".GAMMA.-METHACRYLOXYPROPYLTRIMETHOXYSILANE", "unii": "JV48X1M2EQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to decrease pathogens on the skin Recommended for repeated use For use when soap and water are not available", "Purpose": "Antiseptic", "Warnings": "For external use only. Avoid contact with the eyes. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Stop use and consult doctor if irritation or redness develops or persists for 72 hours.", "Directions": "Wet hands and work in thoroughly, allow to dry without wiping.", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Avoid freezing and excessive heat above 40°C.", "Inactive Ingredients": "Dihydroxyethyl Cocamine Oxiide (Surfactant), Purified Water, 3-(Trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.", "Keep out of reach of children.": "In case swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:23.699462 · Updated: 2026-03-14T23:01:24.251815