Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID d96c6ad2-c7e9-4079-9db2-59d108f284bb
Route
TOPICAL
Published
Effective Date 2017-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.33 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-01-01

Description

Active Ingredient Benzalkonium Chloride, 0.133% w/v


Medication Information

Indications and Usage

Antiseptic Cleansing of face, hands and body without soap and water, Air dries in seconds. USE:

Dosage and Administration

Tear open packet, unfold and use as a washcloth. DIRECTIONS:

Description

Active Ingredient Benzalkonium Chloride, 0.133% w/v

Section 50565-1

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

Section 51727-6

Purified Water INACTIVE INGREDIENTS:

Section 55105-1

Purpose

First Aid Antiseptic

Section 55106-9

Active Ingredient

Benzalkonium Chloride, 0.133% w/v

Stop Use:

if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

Do Not Use:

 in the eyes or apply over larger area of the body.

Package Label


Structured Label Content

Indications and Usage (34067-9)

Antiseptic Cleansing of face, hands and body without soap and water, Air dries in seconds. USE:

Dosage and Administration (34068-7)

Tear open packet, unfold and use as a washcloth. DIRECTIONS:

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Purified Water INACTIVE INGREDIENTS:

Section 55105-1 (55105-1)

Purpose

First Aid Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride, 0.133% w/v

Stop Use: (STOP USE:)

if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

Do Not Use: (DO NOT USE:)

 in the eyes or apply over larger area of the body.

Package Label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)