SPL v1
SPL
SPL Set ID b34b4653-65bd-2fa1-e053-2a95a90a9d9a
Route
TOPICAL
Published
Effective Date 2020-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Fragrance Lemon Orc2001060 Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-01
Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses

For hand cleaning to help reduce bacteria that can cause disease.

Warnings

For External Use Only

Directions
  • Remove the wipe from the center of the canister.
  • Wipe hands.
  • Properly dispose of wipe in a waste container.
  • Children under 6 should be supervised during use.
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredients

ethanol, fragrance, and purified water

Stop Use and Ask Doctor

If irritation and redness develop

When Using This Product

do not get into eyes

if contact occurs, rinse thoroughly with water

Stop Use and Ask A Doctor

If irritation and redness develop

Keep Out of Reach of Children.

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

Package Label Principal Display Panel

1 (100 ct) 75508-006-01

Structured Label Content

Uses

For hand cleaning to help reduce bacteria that can cause disease.

Purpose

Antimicrobial

Warnings

For External Use Only

Directions
  • Remove the wipe from the center of the canister.
  • Wipe hands.
  • Properly dispose of wipe in a waste container.
  • Children under 6 should be supervised during use.
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredients

ethanol, fragrance, and purified water

Stop Use and Ask Doctor (Stop use and ask doctor)

If irritation and redness develop

When Using This Product (When using this product)

do not get into eyes

if contact occurs, rinse thoroughly with water

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

If irritation and redness develop

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

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

Package Label Principal Display Panel (Package Label - Principal Display Panel)

1 (100 ct) 75508-006-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:59.690964 · Updated: 2026-03-14T22:58:49.351511