SPL v3
SPL
SPL Set ID d21c108f-9cc1-46c9-e053-2995a90a2e7e
Route
TOPICAL
Published
Effective Date 2021-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Lauramine Oxide Water Peg-120 Methyl Glucose Dioleate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-02
Description

Benzalkonium Chloride 0.1%

Purpose

Skin Antimicrobial

Medication Information

Purpose

Skin Antimicrobial

Description

Benzalkonium Chloride 0.1%

Uses

reduces amount of bacteria on hands

Section 51945-4

Warnings

For external use only: hands.

Directions

Dispense an adequate amount in your palm to cover all surfaces of both hands completely. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Parfum.

Questions Or Comments?

813-815-0530 or www.protectuguard.com

When Using This Product

do not use in or near eyes. In case of eye contact, flush thoroughly with water. Do not inhale or ingest.

Stop Use and Ask Doctor If

irritation or redness develops. 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.

Structured Label Content

Uses

reduces amount of bacteria on hands

Section 51945-4 (51945-4)

Purpose

Skin Antimicrobial

Warnings

For external use only: hands.

Directions

Dispense an adequate amount in your palm to cover all surfaces of both hands completely. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Parfum.

Questions Or Comments? (Questions or comments?)

813-815-0530 or www.protectuguard.com

When Using This Product (When using this product)

do not use in or near eyes. In case of eye contact, flush thoroughly with water. Do not inhale or ingest.

Stop Use and Ask Doctor If (Stop use and ask doctor if)

irritation or redness develops. 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:10.294821 · Updated: 2026-03-14T23:06:36.654428