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
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses

Hand sanitizer to decrease pathogens on the skin

Recommended for repeated use

For use when soap and water are not available

Lable

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.

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.

Structured Label Content

Uses

Hand sanitizer to decrease pathogens on the skin

Recommended for repeated use

For use when soap and water are not available

Lable

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 doctorif 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. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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