83502-001 Update

SPL v2

SPL

SPL Set ID fcb9fe65-837c-011b-e053-6294a90a4605

Route

TOPICAL

Published

Effective Date 2023-05-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.15 g)

Inactive Ingredients

Peg-10 Dimethicone (220 Cst) Peg-175 Distearate Didecyldimonium Chloride Glycerin Propylene Glycol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-05-27

Description

Benzalkonium chloride 0.15 %

Purpose

For hand sanitizing to decrease bacteria on the skin

Medication Information

Purpose

For hand sanitizing to decrease bacteria on the skin

Description

Benzalkonium chloride 0.15 %

Use

For hand sanitizing to decrease bacteria on the skin

Stop Use

if irritation or rashappears and lasts

Warnings

For external use only

Ask Doctor

if irritation or rashappears and lasts

Directions

Pump a small amount of foam into palm of handRub thoroughly over all surfaces of both handsRub hands together briskly until dry

Do Not Use

in or near the eyes in case of contact, rinse eyes thoroughly with water

When Using

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

Active Ingredient

Benzalkonium chloride 0.15 %

Inactive Ingredients

Water, Didecyldimonium Chloride, Glycerin, PropyleneGlycol, Peg-10 Dimethicone, Peg-17 Dimethicone

Principal Display Panel

Keep Oot of Reach of Children

lf swallowed, getmedical help or contact a Poison Control Center right

Structured Label Content

Use

For hand sanitizing to decrease bacteria on the skin

Purpose

For hand sanitizing to decrease bacteria on the skin

Stop Use

if irritation or rashappears and lasts

Warnings

For external use only

Ask Doctor

if irritation or rashappears and lasts

Directions

Pump a small amount of foam into palm of handRub thoroughly over all surfaces of both handsRub hands together briskly until dry

Do Not Use (Do not use)

in or near the eyes in case of contact, rinse eyes thoroughly with water

When Using

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

Active Ingredient

Benzalkonium chloride 0.15 %

Inactive Ingredients (Inactive ingredients)

Water, Didecyldimonium Chloride, Glycerin, PropyleneGlycol, Peg-10 Dimethicone, Peg-17 Dimethicone

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

lf swallowed, getmedical help or contact a Poison Control Center right

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PEG-10 DIMETHICONE (220 CST)", "unii": "287GF3Y3WC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-175 DISTEARATE", "unii": "96X9M8B71Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIDECYLDIMONIUM CHLORIDE", "unii": "JXN40O9Y9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizing to decrease bacteria on the skin", "Purpose": "For hand sanitizing to decrease bacteria on the skin", "Stop Use": "if irritation or rashappears and lasts", "Warnings": "For external use only", "Ask Doctor": "if irritation or rashappears and lasts", "Directions": "Pump a small amount of foam into palm of handRub thoroughly over all surfaces of both handsRub hands together briskly until dry", "Do not use": "in or near the eyes in case of contact, rinse eyes thoroughly with water", "When Using": "Pay attention to the method of use. do not touch eyes", "Active Ingredient": "Benzalkonium chloride 0.15 %", "Inactive ingredients": "Water, Didecyldimonium Chloride, Glycerin, PropyleneGlycol, Peg-10 Dimethicone, Peg-17 Dimethicone", "Keep Oot Of Reach Of Children": "lf swallowed, getmedical help or contact a Poison Control Center right"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.331505 · Updated: 2026-03-14T23:06:45.911086