Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2
Route
TOPICAL
Published
Effective Date 2017-08-23
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 Completed Since 2012-11-21 Until 2026-03-05

Description

Benzalkonium chloride, 0.13% v/v

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Benzalkonium chloride, 0.13% v/v

Uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Section 42229-5
  • Do not use in the eyes or apply over large areas of the body.
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • Stop use and consult a doctor if the condition persists or gets worse.
  • Do not use for longer than 1 week unless directed by a doctor.

Section 50565-1

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

Section 51945-4

Place holder text











Warnings

For External Use Only

Directions
  • Tear open pouch and use as part of your daily cleansing routine.
  • Clean the affected area.
  • Apply this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.
Other Information

Store at room temperature between 59-86 oF (15-30 oC). If contact with eyes occurs, flush eyes with water.

Active Ingredients

Benzalkonium chloride, 0.13% v/v

Inactive Ingredients

Purified water

Questions Or Comments?

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST


Structured Label Content

Uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Section 42229-5 (42229-5)
  • Do not use in the eyes or apply over large areas of the body.
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • Stop use and consult a doctor if the condition persists or gets worse.
  • Do not use for longer than 1 week unless directed by a doctor.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Place holder text











Purpose

First Aid Antiseptic

Warnings

For External Use Only

Directions
  • Tear open pouch and use as part of your daily cleansing routine.
  • Clean the affected area.
  • Apply this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.
Other Information

Store at room temperature between 59-86 oF (15-30 oC). If contact with eyes occurs, flush eyes with water.

Active Ingredients

Benzalkonium chloride, 0.13% v/v

Inactive Ingredients

Purified water

Questions Or Comments? (Questions or comments?)

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)