b4e1760a-fbfd-6943-e053-2a95a90ac952

SPL v3

SPL

SPL Set ID b4e1760a-fbfd-6943-e053-2a95a90ac952

Route

topical

Published

Effective Date 2020-11-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

lactic acid edetate sodium peg-7 glyceryl cocoate sodium benzoate phenoxyethanol water cocamidopropyl betaine propylene glycol

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-11-24

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings

For External use only

Uses

For hand sanitizing to decrease bacteria on the skin

Purpose

Antiseptic

Directions

Apply enough product to cover hands
Rub together until dry without wiping

Other Information

Store at room temperature

Inactive Ingredients

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid

Description

Benzalkonium chloride 0.13%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor

if irritation or redness develops
condition persists for more than 72 hours

Section 50567-7

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 51945-4

For

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

Active Ingredients

Benzalkonium chloride 0.13%

Structured Label Content

Warnings (WARNINGS)

For External use only

Uses

For hand sanitizing to decrease bacteria on the skin

Purpose

Antiseptic

Directions

Apply enough product to cover hands
Rub together until dry without wiping

Other Information

Store at room temperature

Inactive Ingredients

water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

if irritation or redness develops
condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

For

sensitive

skin

0% Alcohol

aeris

guard

ACTISAN

Hand Sanitizer

Complies with EN-13727-Bactericidal test

For sensitive skin Leaves soft skin feel

Contains moisturizer and emollient Mild and skin compatible

Non-tacky

Active moisturizer

Fragrance free and pH balanced

ALCOHOL

FREE

NET CONTENTS

3.5 fl. oz. (103mL)

Active Ingredients

Benzalkonium chloride 0.13%

Advanced Ingredient Data

[{"name": "LACTIC ACID", "unii": "33X04XA5AT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-7 GLYCERYL COCOATE", "unii": "VNX7251543", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": "For hand sanitizing to decrease bacteria on the skin", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours", "50567-7": "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.", "51945-4": "For sensitive skin 0% Alcohol aeris guard ACTISAN Hand Sanitizer Complies with EN-13727-Bactericidal test For sensitive skin Leaves soft skin feel Contains moisturizer and emollient Mild and skin compatible Non-tacky Active moisturizer Fragrance free and pH balanced ALCOHOL FREE NET CONTENTS 3.5 fl. oz. (103mL)", "Purpose": "Antiseptic", "WARNINGS": "For External use only", "Directions": "Apply enough product to cover hands Rub together until dry without wiping", "Other Information": "Store at room temperature", "Active Ingredients": "Benzalkonium chloride 0.13%", "Inactive Ingredients": "water, cocamidopropyl betaine, PEG-7 glyceryl cocoate, propylene glycol, tetrasodium edta, phenoxyethanol, sodium benzoate, lactic acid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:26.203724 · Updated: 2026-03-14T23:00:51.196726