Hand Sanitizer

SPL v7

SPL

SPL Set ID dbd86ed2-3bcc-67cd-e053-2995a90a9697

Route

TOPICAL

Published

Effective Date 2022-04-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Polysorbate 80 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-04-26

Description

Benzalkonium Cl 0.13%

Indications and Usage

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Purpose

Antiseptic

Medication Information

Indications and Usage

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Purpose

Antiseptic

Description

Benzalkonium Cl 0.13%

Uses

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Warnings

For external use only.

Do Not Use

in or near eyes.

Directions

Spray as neeeded
Rub hands together covering all areas, including fingernail areas thoroughly

Active Ingredient

Benzalkonium Cl 0.13%

Other Information

store at 2ºC to 40ºC (35.6ºF to 104ºF)

Inactive Ingredients

polysorbate 80, proprietary blend of natural botanical oils, water

Dosage & Administration

300+ Sprays

Principal Display Panel

Stop Use and Ask A Doctor If

redness or irritation develop or persist for more than 72 hours.

Keep Out of Reach of Children

unless under adult supervision. If swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only.

Do Not Use (DO NOT USE)

in or near eyes.

Directions

Spray as neeeded
Rub hands together covering all areas, including fingernail areas thoroughly

Active Ingredient

Benzalkonium Cl 0.13%

Other Information

store at 2ºC to 40ºC (35.6ºF to 104ºF)

Inactive Ingredients

polysorbate 80, proprietary blend of natural botanical oils, water

Indications and Usage

Leave on hand sanitizer to decrease harmful bacteria on the skin.

Dosage & Administration

300+ Sprays

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

redness or irritation develop or persist for more than 72 hours.

Keep Out of Reach of Children (Keep out of reach of children)

unless under adult supervision. If swallowed get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Leave on hand sanitizer to decrease harmful bacteria on the skin.", "Purpose": "Antiseptic", "Warnings": "For external use only.", "DO NOT USE": "in or near eyes.", "Directions": "Spray as neeeded Rub hands together covering all areas, including fingernail areas thoroughly", "Active Ingredient": "Benzalkonium Cl 0.13%", "Other Information": "store at 2ºC to 40ºC (35.6ºF to 104ºF)", "Inactive Ingredients": "polysorbate 80, proprietary blend of natural botanical oils, water", "Indications and Usage": "Leave on hand sanitizer to decrease harmful bacteria on the skin.", "Dosage & Administration": "300+ Sprays", "Stop use and ask a doctor if": "redness or irritation develop or persist for more than 72 hours.", "Keep out of reach of children": "unless under adult supervision. If swallowed get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:14.537935 · Updated: 2026-03-14T23:00:36.247175