83502-003 update

SPL v2

SPL

SPL Set ID fcbc3c5d-c231-9024-e053-6294a90a9c59

Route

topical

Published

Effective Date 2023-05-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.1 g)

Inactive Ingredients

didecyldimonium chloride phenoxyethanol water

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-05-27

Purpose

For hand sanitizing to decrease bacteria on the skin

Description

Benzalkonium chloride 0.1%

Medication Information

Warnings

For external use only

Purpose

For hand sanitizing to decrease bacteria on the skin

Directions

Spray a small amount in your palm and Rob hands together briskly until dry

Inactive Ingredients

Water, Didecyldimonium Chloride, Phenoxvethanol

Description

Benzalkonium chloride 0.1%

Principal Display Panel

Use

Avoid contact with eyes

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts

Ask Doctor

if irritation or rashappears and lastsa

Do Not Use

Do not use in or near the eyes

in case of contact,rinse eyes thoroughly

When Using

Pay attention to the method of use. do not touch eyes

Active Ingredient

Benzalkonium chloride 0.1%

Keep Oot of Reach of Children

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

Structured Label Content

Warnings

For external use only

Purpose

For hand sanitizing to decrease bacteria on the skin

Directions

Spray a small amount in your palm and Rob hands together briskly until dry

Inactive Ingredients (Inactive ingredients)

Water, Didecyldimonium Chloride, Phenoxvethanol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Avoid contact with eyes

Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts

Ask Doctor

if irritation or rashappears and lastsa

Do Not Use (Do not use)

Do not use in or near the eyes

in case of contact,rinse eyes thoroughly

When Using

Pay attention to the method of use. do not touch eyes

Active Ingredient

Benzalkonium chloride 0.1%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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

Advanced Ingredient Data

[{"name": "DIDECYLDIMONIUM CHLORIDE", "unii": "JXN40O9Y9B", "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": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Avoid contact with eyes", "Purpose": "For hand sanitizing to decrease bacteria on the skin", "Stop Use": "Stop use and ask a doctor if irritation or rash appears and lasts", "Warnings": "For external use only", "Ask Doctor": "if irritation or rashappears and lastsa", "Directions": "Spray a small amount in your palm and Rob hands together briskly until dry", "Do not use": "Do not use in or near the eyes in case of contact,rinse eyes thoroughly", "When Using": "Pay attention to the method of use. do not touch eyes", "Active Ingredient": "Benzalkonium chloride 0.1%", "Inactive ingredients": "Water, Didecyldimonium Chloride, Phenoxvethanol", "Keep Oot 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: 2026-02-15T12:05:15.333352 · Updated: 2026-03-14T23:06:45.911086