Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 02f63d50-e4ff-49b6-9f8c-fddceefe65f3
Route
TOPICAL
Published
Effective Date 2013-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.133 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-27

Description

Benzalkonium Chloride 0.133%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.133%

Uses

For topical antimicrobial use

Section 50565-1

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

Warnings

For external use only

■ flammable, keep away from fire or flame

Directions

■wipe the required site vigorously and discard

Do Not Use

■ with electrocautery procedures ■ in the eyes, if contact occurs, flush eyes with water

Package Label

Active Ingredient

Benzalkonium Chloride 0.133%

Other Information

■ store at room temperature 15C-30C (59F-86F)

Inactive Ingredients

purified water, camphor

Stop Use and Ask A Doctor If

■if irritation and redness develops. if condition persist consult your health practitioner.


Structured Label Content

Uses

For topical antimicrobial use

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

For external use only

■ flammable, keep away from fire or flame

Directions

■wipe the required site vigorously and discard

Do Not Use (Do not use)

■ with electrocautery procedures ■ in the eyes, if contact occurs, flush eyes with water

Package Label

Active Ingredient

Benzalkonium Chloride 0.133%

Other Information (Other information)

■ store at room temperature 15C-30C (59F-86F)

Inactive Ingredients

purified water, camphor

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

■if irritation and redness develops. if condition persist consult your health practitioner.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)