Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID cf4a6a97-529e-7f11-e053-2a95a90a75a9
Route
TOPICAL
Published
Effective Date 2023-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-17

Description

Benzalkonium Chloride 0.13% w/w.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13% w/w.

Use

For handwashing to decrease bacteria on skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center immediately.

Section 50566-9

Stop use and ask a doctor If irritation or redness develops and persists for more than 72 hours.

Warnings

For external use only

Directions
  • Tear open packet, unfold and use as a washcloth
  • Allow hands to dry without wiping
Do Not Use
  • in the eyes. If this happens, rinse thoroughly with water.
Antiseptic Wipe

Active Ingredient

Benzalkonium Chloride 0.13% w/w.

Inactive Ingredient

water


Structured Label Content

Use

For handwashing to decrease bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor If irritation or redness develops and persists for more than 72 hours.

Purpose

Antiseptic

Warnings

For external use only

Directions
  • Tear open packet, unfold and use as a washcloth
  • Allow hands to dry without wiping
Do Not Use (Do not use)
  • in the eyes. If this happens, rinse thoroughly with water.
Antiseptic Wipe

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w.

Inactive Ingredient (Inactive ingredient)

water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)