Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a4b227a0-a368-45d9-b33f-be6c0a9f63f1

Route

TOPICAL

Published

Effective Date 2011-10-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.1 mL)

Inactive Ingredients

Water Hypromelloses Polyoxyl 40 Hydrogenated Castor Oil Trideceth-9 Propylene Glycol Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-10-06

Description

BENZALKONIUM CHLORIDE 0.1%

Purpose

ANTIMICROBIAL

Medication Information

Purpose

ANTIMICROBIAL

Description

BENZALKONIUM CHLORIDE 0.1%

Uses

TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEAT USE.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient

BENZALKONIUM CHLORIDE 0.1%

Inactive Ingredients

WATER, POLYQUATERNIUM-37, HYDROXYETHYLCELLULOSE, PEG-40 HYDROGENATED CASTOR OIL, TRIDECETH-9, PROPYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE.

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Stop Using This Product and Ask Doctor If

IRRITATION OR RASH DEVELOPS AND LASTS.

Structured Label Content

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEAT USE.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTIMICROBIAL

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.
CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.1%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, POLYQUATERNIUM-37, HYDROXYETHYLCELLULOSE, PEG-40 HYDROGENATED CASTOR OIL, TRIDECETH-9, PROPYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE.

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

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.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR RASH DEVELOPS AND LASTS.

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIDECETH-9", "unii": "X9HD79I514", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TO HELP REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEAT USE.", "PURPOSE": "ANTIMICROBIAL", "WARNINGS": "FOR EXTERNAL USE ONLY.", "DIRECTIONS": "APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.", "ACTIVE INGREDIENT": "BENZALKONIUM CHLORIDE 0.1%", "INACTIVE INGREDIENTS": "WATER, POLYQUATERNIUM-37, HYDROXYETHYLCELLULOSE, PEG-40 HYDROGENATED CASTOR OIL, TRIDECETH-9, PROPYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE.", "WHEN USING THIS PRODUCT": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.", "KEEP OUT OF REACH OF CHILDREN": "IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.", "STOP USING THIS PRODUCT AND ASK DOCTOR IF": "IRRITATION OR RASH DEVELOPS AND LASTS."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.034899 · Updated: 2026-03-14T22:52:53.430326