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SPL v2

SPL

SPL Set ID d02e7e72-2085-43a4-8a26-44b24b284a45

Route

topical

Published

Effective Date 2020-04-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

aloe vera leaf glycerin polysorbate 20 water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2019-09-15

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Purpose

Antiseptic

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, Water

Description

Benzalkonium Chloride 0.13%

Use

for handwashing to decrease bacteria on the skin

Section 53413-1

TO REPORT A SERIOUS ADVERSE EVENT, CONTACT 1-800-334-4577

Do Not Use

in the eyes

Active Ingredient

Benzalkonium Chloride 0.13%

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

Package Labeling: 72487 003 08

Package Labeling: 72487 004 00

Structured Label Content

Warnings

For external use only.

Purpose

Antiseptic

Directions

wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, Water

Use

for handwashing to decrease bacteria on the skin

Section 53413-1 (53413-1)

TO REPORT A SERIOUS ADVERSE EVENT, CONTACT 1-800-334-4577

Do Not Use (Do not use )

in the eyes

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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

Package Labeling: 72487 003 08 (Package Labeling: 72487-003-08)

Package Labeling: 72487 004 00 (Package Labeling: 72487-004-00)

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "for handwashing to decrease bacteria on the skin", "53413-1": "TO REPORT A SERIOUS ADVERSE EVENT, CONTACT 1-800-334-4577", "Purpose": "Antiseptic", "Warnings": "For external use only.", "Directions": "wet hands thoroughly with product and allow to dry without wiping", "Do not use ": "in the eyes", "Active ingredient": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Aloe Barbadensis Leaf Juice, Glycerin, Polysorbate 20, Water", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:46.689846 · Updated: 2026-03-14T22:58:30.214848