SPL v2
SPL
SPL Set ID d1819e40-89ba-41fd-873a-705dfd3d0d48
Route
TOPICAL
Published
Effective Date 2013-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-01

Description

Drug Facts

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Drug Facts

Uses
  • Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

Section 50570-1

Do not use in the eyes. If this happens, rinse thoroughly with water.

Warnings

For external use only

Directions
  • tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredients

alcohol, water

Principal Display Panel – Packet Label

NDC 55550-200-00

Antiseptic

Towelette



Benzalkonium Chloride/

First Aid Antiseptic




1 SINGLE-USE

PREMOISTENED TOWELETTE


Structured Label Content

Uses
  • Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water
Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

Section 50570-1 (50570-1)

Do not use in the eyes. If this happens, rinse thoroughly with water.

Purpose

First Aid Antiseptic

Warnings

For external use only

Directions
  • tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.
Active Ingredients (Active ingredients)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

alcohol, water

Principal Display Panel – Packet Label (PRINCIPAL DISPLAY PANEL – packet label)

NDC 55550-200-00

Antiseptic

Towelette



Benzalkonium Chloride/

First Aid Antiseptic




1 SINGLE-USE

PREMOISTENED TOWELETTE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)