955295ae-a7be-460e-8e4b-5937ef6d53e7

SPL v1

SPL

SPL Set ID 955295ae-a7be-460e-8e4b-5937ef6d53e7

Route

topical

Published

Effective Date 2022-05-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.1 g)

Inactive Ingredients

sodium cocoate glycerin titanium dioxide water sodium tallowate, beef

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph not final active Since 2022-06-01

Purpose

Antibacterial

Description

Benzalkonium chloride 0.1%

Medication Information

Warnings

For external use only

Do not use in eyes

Stop use and ask a doctor if

Irritation and redness develop

Condition persist for more than 72 hours

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

Uses

For hand washing to decrease bacteria on the skin

Purpose

Antibacterial

Inactive Ingredients

Fragrance, gliceryn, sodium cocoate, sodium tallowate, titanium dioxide, colors.

Description

Benzalkonium chloride 0.1%

Direction

Wet hands and forearms. Apply to hands and forearms. Scrub thoroughly for 30-60 seconds. Rinse and repeat.

Product Label

Active Ingredient

Benzalkonium chloride 0.1%

Structured Label Content

Warnings

For external use only

Do not use in eyes

Stop use and ask a doctor if

Irritation and redness develop

Condition persist for more than 72 hours

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

Uses

For hand washing to decrease bacteria on the skin

Purpose

Antibacterial

Inactive Ingredients (Inactive ingredients)

Fragrance, gliceryn, sodium cocoate, sodium tallowate, titanium dioxide, colors.

Direction

Wet hands and forearms. Apply to hands and forearms. Scrub thoroughly for 30-60 seconds. Rinse and repeat.

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.1%

Advanced Ingredient Data

[{"name": "SODIUM COCOATE", "unii": "R1TQH25F4I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM TALLOWATE, BEEF", "unii": "07RIK6QMEW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For hand washing to decrease bacteria on the skin", "Purpose": "Antibacterial", "Warnings": " For external use only Do not use in eyes Stop use and ask a doctor if Irritation and redness develop Condition persist for more than 72 hours Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away ", "Direction": "Wet hands and forearms. Apply to hands and forearms. Scrub thoroughly for 30-60 seconds. Rinse and repeat.", "Active ingredient": "Benzalkonium chloride 0.1%", "Inactive ingredients": "Fragrance, gliceryn, sodium cocoate, sodium tallowate, titanium dioxide, colors."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:13.873034 · Updated: 2026-03-14T23:00:36.247175